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OUTSET MEDICAL INC

TABLO · Hematology

510(k): 9 Recall: 5 UDI: 22 MAUDE: 10 Class.: 56

510(k) Clearances (9)

Tablo Hemodialysis System (PN-0008000, PN-0006000U)
2026-01-26

Substantially Equivalent

Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
2024-05-03

Substantially Equivalent

Tablo® Hemodialysis System
2023-12-05

Substantially Equivalent

Tablo® Hemodialysis System
2023-06-21

Substantially Equivalent

Tablo Hemodialysis System
2022-07-29

Substantially Equivalent

Tablo Cartridge
2021-11-26

Substantially Equivalent

Tablo Hemodialysis System
2020-03-31

Substantially Equivalent

Tablo Hemodialysis System, Tablo Cartridge
2019-12-12

Substantially Equivalent

Tablo Console
2016-11-15

Substantially Equivalent

Recalls (5)

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
2024-08-01

Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.

TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
2024-04-30

A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
2024-03-06

Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.

Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
2023-01-24

An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
2022-01-20

Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

UDI Registrations (22)

Tablo(R) Hemodialysis System

The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.

Tablo(R) Cartridge

The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis.

Tablo(R) Cartridge

Tablo X Cartridge with Needleless Infusion Ports

Tablo(R) Straws

Straws, for concentrate bottles

Tablo Hemodialysis Concentrate

Liquid bicarbonate concentrate, 45X, 1 U.S. gallon

Tablo Cartridge
Tablo Hemodialysis Concentrate

Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon

Tablo(R) Hemodialysis System

Tablo Console

Tablo(R) Cartridge

Tablo X Cartridge, OMM

Tablo(R) Straws

Straws, for concentrate bottles

Tablo(R) Hemodialysis System

Tablo Console

Tablo Straws
Tablo(R) Disinfectant Straws

Straws for disinfectant bottle

Tablo Needleless Cartridge, B

Tablo Cartridge with Needleless Infusion Ports Type B

Tablo Hemodialysis Concentrate

Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon

Tablo Hemodialysis Concentrate

Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon

Tablo(R) Cartridge

Tablo Cartridge, Needleless, X, with Formula Organizer

Tablo(R) Hemodialysis System

Tablo Console

Tablo Hemodialysis Console
Tablo(R) Hemodialysis System

Tablo Console

Tablo(R) Cartridge

Tablo X Cartridge with Needleless Infusion Ports

Tablo Cartridge

Tablo Cartridge with Needleless Infusion Ports

MAUDE Adverse Events (10)

Death
20200807
Injury
20200806
Injury
20200802
Death
20200720
Injury
20200529
Injury
20200526
Death
20200502
Death
20200327
Death
20200324
Injury
20200120

FDA Classification (56)

Assay, Heparin

Hematology

Adamts13 Activity Test System

Hematology

Stain, Papanicolau

Hematology

Tablet, Resazurin

Hematology

Solution, Silver Carbonate

Hematology

Ethyl Eosin

Hematology

Lymphocyte Separation Medium

Hematology

Microscope, Automated, Image Analysis, Operator Intervention

Hematology

Test, Sickle Cell

Hematology

Nigrosin

Hematology

Control, Platelet

Hematology

Oxyhemoglobin

Hematology

Plasma, Coagulation Control

Hematology

Indigocarmine

Hematology

Antithrombin Iii Quantitation

Hematology

Dna-Probe, B And T Lymphocyte

Hematology

Stains, Chemical Solution

Hematology

Neutral Red

Hematology

Reagent, Schiff

Hematology

Reagent, Russel Viper Venom

Hematology

Romanowsky Stains

Hematology

Centrifuge, Microsedimentation

Hematology

Giemsa Stain

Hematology

Adenine Nucleotide Quantitation

Hematology

Stains, Microbiologic

Hematology

Separator, Automated, Blood Cell, Diagnostic

Hematology

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

Hematology

Analyzer, Chromosome, Automated

Hematology

Immunohistochemistry Reagents And Kits

Hematology

Products, Red-Cell Lysing Products

Hematology

Carbol Fuchsin

Hematology

Counter, Differential Cell

Hematology

Control Material, Blood Circulating Epithelial Cancer Cell

Hematology

Hemoglobinometer

Hematology

Crystal Violet For Histology

Hematology

Warmer, Blood, Non-Electromagnetic Radiation

Hematology

System, Automated Platelet Aggregation

Hematology

Whole Blood Hemoglobin Determination

Hematology

Jenner Stain

Hematology

Red-Cell Count By Photometry

Hematology

Stains, Heinz Body

Hematology

Fluid, Diluting, Red-Cell

Hematology

Reagent, Thromboplastin And Control

Hematology

Hematoxylin, Chrome Alum

Hematology

Reagent & Control, Partial Thromboplastin Time

Hematology

Hemoglobin For Donor Testing

Hematology

Carmine

Hematology

Bothrops Atrox Reagent

Hematology

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Hematology

Auramine O

Hematology

Assay, Glycosylated Hemoglobin

Hematology

Mucicarmine

Hematology

Control, Hemoglobin

Hematology

Red-Cell Indices, Measured

Hematology

Blood Establishment Computer Software And Accessories

Hematology

Van Gieson'S Picro-Fuchsin

Hematology