510(k) Report

FDA applicant

Convatec, A Bristol-Myers Squibb Co.

Skillman, NJ10 decisions1994–20043 recalls

FDA records 10 decisions for Convatec, A Bristol-Myers Squibb Co. (Skillman, NJ) from 1994 to 2004: 10 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Convatec, A Bristol-Myers Squibb Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Convatec, A Bristol-Myers Squibb Co. since 2007.

Recalls per year

2in 2013

2008: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Convatec, A Bristol-Myers Squibb Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Convatec, A Bristol-Myers Squibb Co.’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, Drug3decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic2decisions
  • KMFBandage, Liquid2decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • EXJDevice, Incontinence, Urosheath Type, Sterile1decision
  • MGPDressing, Wound And Burn, Occlusive1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 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.

  • K982116Aquacel Hydrofiber Wound DressingConvatec, A Bristol-Myers Squibb Co. · 19983cite it
  • K032734Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 20042cite it
  • K973806Duoderm Hydroactive GelConvatec, A Bristol-Myers Squibb Co. · 19972cite it
  • K990368Duoderm Hydroactive Gel Wound DressingConvatec, A Bristol-Myers Squibb Co. · 19991cites it
  • K973716Duoderm Extra Thin CGF DressingConvatec, A Bristol-Myers Squibb Co. · 19971cites it

What has FDA decided for it lately?

  • K032734Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 20043 recalls
  • K990368Duoderm Hydroactive Gel Wound DressingConvatec, A Bristol-Myers Squibb Co. · 1999
  • K982116Aquacel Hydrofiber Wound DressingConvatec, A Bristol-Myers Squibb Co. · 1998
  • K973806Duoderm Hydroactive GelConvatec, A Bristol-Myers Squibb Co. · 1997
  • K973807Duoderm Hydroactive PasteConvatec, A Bristol-Myers Squibb Co. · 1997
  • K973716Duoderm Extra Thin CGF DressingConvatec, A Bristol-Myers Squibb Co. · 1997
  • K973717Combiderm AcdConvatec, A Bristol-Myers Squibb Co. · 1997
  • K954918Combiderm AcdConvatec, A Bristol-Myers Squibb Co. · 1995

All 10 as Convatec, A Bristol-Myers Squibb Co. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K032734ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to…Jun 25, 2013Class III
  • K032734ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal…Jun 25, 2013Class III
  • K032734Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone…Nov 20, 2008

Other applicant names beginning “Convatec”

FDA records each applicant name separately; these may or may not be the same firm.

Convatec, A Division of E.R. Squibb & Sons 84Convatec Limited 29Convatec Triad Life Sciences, LLC 1Convatec Limited, Gdc Building 1