510(k) Report

FDA applicant

Flashback Technologies, Inc.

Westfield, NJ3 decisions2016–20220 recalls

FDA records 3 decisions for Flashback Technologies, Inc. (Westfield, NJ) from 2016 to 2022: 2 510(k) clearances and 1 De Novo grant. All are in product code PPW (Adjunctive Cardiovascular Status Indicator). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2022

2016: 12018: 12022: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Flashback Technologies, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PPWAdjunctive Cardiovascular Status Indicator3decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • DEN160020CipherOx CRI TabletFlashback Technologies, Inc. · 20162cite it
  • K173929CipherOx CRI M1Flashback Technologies, Inc. · 20181cites it

What has FDA decided for it lately?

  • K213255CipherOx CRI TabletFlashback Technologies, Inc. · 2022
  • K173929CipherOx CRI M1Flashback Technologies, Inc. · 2018
  • DEN160020CipherOx CRI TabletFlashback Technologies, Inc. · 2016

All 3 as Flashback Technologies, Inc. →