510(k) Report

FDA applicant

Synedgen, Inc.

Claremont, CA3 decisions2015–20200 recalls

FDA records 3 decisions for Synedgen, Inc. (Claremont, CA) from 2015 to 2020: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and OLR (Oral Wound Dressing). Its devices cite 4 predicates, 0 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

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

FDA decisions per year

1in 2020

2015: 12018: 12020: 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 — Synedgen, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Synedgen, 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?

  • FRODressing, Wound, Drug2decisions
  • OLROral Wound Dressing1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseSynedgen, Inc. · 2020
  • K172338Catasyn Advanced Technology Wound HydrogelSynedgen, Inc. · 2018
  • K143444SynePure Wound CleanserSynedgen, Inc. · 2015

All 3 as Synedgen, Inc. →