FDA.reportPublic FDA data

Tablo(R) Hemodialysis System

Primary DI
00850001011341
Brand
Tablo(R) Hemodialysis System
Company
Outset Medical, Inc.
Model
PN-0007001
Device description
Tablo Console
Published
2025-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200741000
K211370000
K223248000
K233335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200741000Tablo Hemodialysis SystemOutset Medical, Inc.2020-03-31KDI
K211370000Tablo Hemodialysis SystemOutset Medical, Inc.2022-07-29KDI
K223248000Tablo® Hemodialysis SystemOutset Medical, Inc.2023-06-21KDI
K233335000Tablo® Hemodialysis SystemOutset Medical, Inc.2023-12-05KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001011341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001011341008500010113418500010113410850001011341

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutional/home-useAn assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(669) 231-8200CS@outsetmedical.com

Regulatory Flags#

DUNS number
788744477
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001011266Tablo(R) Hemodialysis SystemPN-00070002025-09-21
00850001011358Tablo(R) Hemodialysis SystemPN-00060012025-09-21
00850001011044Tablo Hemodialysis ConcentratePN-0000832A-2252016-01-29
00850001011051Tablo Hemodialysis ConcentratePN-0000833A-3252016-01-29
00850001011075Tablo CartridgePN-0002305CART-2002017-04-11
00850001011136Tablo(R) StrawsPN-00042112020-08-03
00850001011167Tablo(R) StrawsPN-0004378PN-0004467, PN-00054512020-08-03
00850001011174Tablo(R) Disinfectant StrawsPN-0004681PN-00046752020-08-03
00850001011211Tablo(R) CartridgePN-0005643PN-00042202022-04-11
10850001011218Tablo(R) CartridgePN-0005643PN-00042202022-04-11
00850001011242Tablo(R) CartridgePN-0006310PN-00042202022-04-11
00850001011259Tablo(R) CartridgePN-0006887PN-00042202024-05-21
00850001011297TabloCart™ with Prefiltration DrawerPN-00069882024-05-17
00850001011303TabloCart™ with Prefiltration DrawerPN-00068132024-05-17
00850001011204Tablo(R) Hemodialysis SystemPN-00060002020-06-17
00850001011273Tablo(R) CartridgePN-0008544PN-00042202024-01-22
00850001011105Tablo Hemodialysis ConcentratePN-0002630A-1252020-08-03
20850001011024Tablo StrawsPN-0000503ST-1002015-11-03
00850001011006Tablo Hemodialysis ConsolePN-00008502015-10-23
00850001011013Tablo CartridgeDWG-3008CART-1002015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
00817927020345AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020352AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020369AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020376AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020383AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020390AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020406AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020413AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
08056992333543HPH-700 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333550HPH-700TS HEMOCONCENTRATMEDICA SPAKDI2026-04-01
08056992333567HPH-400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333581HPH-1400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333598HPH-400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333628HPH JUNIORMEDICA SPAKDI2026-04-01
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790011914Nipro Set Blood Tubing SetNIPRO MEDICAL CORPORATIONKDI2025-06-01
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
00085412908397RevaclearBaxter Healthcare SAKDI2024-04-12
00085412908427RevaclearBaxter Healthcare SAKDI2024-04-12
00085412908434RevaclearBaxter Healthcare SAKDI2024-04-12
M535NX100010G0VersiHD with GuideMe softwareNXSTAGE MEDICAL, INC.KDI2024-01-25
M535FWS3090EXPRESS FLUID WARMER DISPOSABLENXSTAGE MEDICAL, INC.KDI2023-11-20