510(k) Report

FDA applicant

Trice Medical, Inc.

King Of Prussia, PA4 decisions2014–20240 recalls

FDA records 4 decisions for Trice Medical, Inc. (King Of Prussia, PA) from 2014 to 2024: 4 510(k) clearances. Most are in product codes HRX (Arthroscope) and LFL (Instrument, Ultrasonic Surgical). Since 2016 its 510(k)s took a median of 33 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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

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

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

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

FDA decisions per year

1in 2024

2014: 12016: 12021: 12024: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Trice Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Trice Medical, 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?

  • HRXArthroscope3decisions
  • LFLInstrument, Ultrasonic Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 33 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K162475mi-eye 2, mi-eye 2 monitorTrice Medical · 20164cite it
  • K141119Camera Enabled ProbeTrice Medical, Inc. · 20141cites it

What has FDA decided for it lately?

  • K241700Tenex 2nd Generation SystemTrice Medical, Inc. · 2024
  • K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc. · 2021
  • K162475mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
  • K141119Camera Enabled ProbeTrice Medical, Inc. · 2014

All 3 as Trice Medical, Inc. →The one decision as Trice Medical →