510(k) Report

FDA applicant

Preceptis Medical

Plymouth, MN5 decisions2014–20220 recalls

FDA records 5 decisions for Preceptis Medical (Plymouth, MN) from 2014 to 2022: 5 510(k) clearances. All are in product code ETD (Tube, Tympanostomy). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Preceptis Medical, Inc.”.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2022

2014: 12015: 22020: 12022: 1
2014high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

Planning a device like Preceptis Medical’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?

  • ETDTube, Tympanostomy5decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 20202cite it
  • K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 20222cite it
  • K142282Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 20151cites it
  • K133921Preceptis Tympanostomy Tube InserterPreceptis Medical · 20141cites it

What has FDA decided for it lately?

  • K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022
  • K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020
  • K151830Hummingbird Tympanostomy TubePreceptis Medical · 2015
  • K142282Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015
  • K133921Preceptis Tympanostomy Tube InserterPreceptis Medical · 2014

All 3 as Preceptis Medical →All 2 as Preceptis Medical, Inc. →