510(k) Report

FDA applicant

Applied Biometrics, Inc.

Eden Prairie, MN3 decisions1987–19920 recalls

FDA records 3 decisions for Applied Biometrics, Inc. (Eden Prairie, MN) from 1987 to 1992: 3 510(k) clearances. Most are in product codes JOP (Transducer, Ultrasonic) and DPW (Flowmeter, Blood, Cardiovascular). 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 Applied Biometrics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Biometrics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Applied Biometrics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Applied Biometrics, 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?

  • JOPTransducer, Ultrasonic2decisions
  • DPWFlowmeter, Blood, Cardiovascular1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K870857Abcom 1 Cardiac Output MonitorApplied Biometrics, Inc. · 19871cites it

What has FDA decided for it lately?

  • K912562ABCOM 2000Applied Biometrics, Inc. · 1992
  • K911320Extravascular Doppler (Evd) Ultra Blood Flow ProbeApplied Biometrics, Inc. · 1991
  • K870857Abcom 1 Cardiac Output MonitorApplied Biometrics, Inc. · 1987

All 3 as Applied Biometrics, Inc. →