510(k) Report

FDA applicant

Outset Medical, Inc.

San Jose, CA10 decisions2015–20265 recalls

FDA records 10 decisions for Outset Medical, Inc. (San Jose, CA) from 2015 to 2026: 10 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJK (Set, Tubing, Blood, With And Without…). Since 2016 its 510(k)s took a median of 235 days from receipt to decision, against 235 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 9 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Outset Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Outset Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12016: 12019: 12020: 12021: 12022: 12023: 22024: 12026 (partial year): 1
2015high 2 (2023) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

3in 2024

2022: 12023: 12024: 3, 1 Class I
2015high 3 (2024) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Outset Medical, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Outset Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System9decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 235 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 235 days; 4 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223248Tablo® Hemodialysis SystemOutset Medical, Inc. · 20233cite it
  • K211370Tablo Hemodialysis SystemOutset Medical, Inc. · 20222cite it
  • K160881Tablo ConsoleOutset Medical, Inc. · 20162cite it
  • K210782Tablo CartridgeOutset Medical, Inc. · 20211cites it
  • K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 20191cites it
  • K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 20231cites it

What has FDA decided for it lately?

  • K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc. · 2026
  • K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc. · 20241 recall
  • K233335Tablo® Hemodialysis SystemOutset Medical, Inc. · 20231 Class I recall
  • K223248Tablo® Hemodialysis SystemOutset Medical, Inc. · 2023
  • K211370Tablo Hemodialysis SystemOutset Medical, Inc. · 20221 recall
  • K210782Tablo CartridgeOutset Medical, Inc. · 2021
  • K200741Tablo Hemodialysis SystemOutset Medical, Inc. · 20201 recall
  • K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 20192 recalls

All 9 as Outset Medical, Inc. →The one decision as Outset Medical →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K233335Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The…Aug 1, 2024Class II
  • K232776TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot)…Apr 30, 2024Class II
  • K233335Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001Mar 6, 2024Class I
  • K190793Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation…Jan 24, 2023Class II
  • K190793Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000Jan 20, 2022Class II