510(k) Report

FDA applicant

Shift Labs, Inc.

Seattle, WA2 decisions2015–20180 recalls

FDA records 2 decisions for Shift Labs, Inc. (Seattle, WA) from 2015 to 2018: 2 510(k) clearances. All are in product code FLN (Monitor, Electric For Gravity Flow Infusion…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Shift Labs”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2018

2015: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

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

See the 510(k) Report

Which product codes does it file in?

  • FLNMonitor, Electric For Gravity Flow Infusion Systems2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150687DripAssistShift Labs · 20151cites it

What has FDA decided for it lately?

  • K172242DripAssist PlusShift Labs, Inc. · 2018
  • K150687DripAssistShift Labs · 2015

The one decision as Shift Labs, Inc. →The one decision as Shift Labs →