510(k) Report

FDA applicant

Collegium Pharmaceutical Incorporated

Cumberland, RI3 decisions2009–20100 recalls

FDA records 3 decisions for Collegium Pharmaceutical Incorporated (Cumberland, RI) from 2009 to 2010: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). Its devices cite 8 predicates, 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

How often FDA has decided Collegium Pharmaceutical Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 22010: 1
2009high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Collegium Pharmaceutical Incorporated by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug2decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 20092cite it
  • K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 20092cite it

What has FDA decided for it lately?

  • K093320Dryodine Cadexomer-Iodine GelCollegium Pharmaceutical Incorporated · 2010
  • K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated · 2009
  • K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated · 2009

All 3 as Collegium Pharmaceutical Incorporated →