510(k) Report

FDA applicant

3M Healthcare Business Group

San Antonio, TX5 decisions2021–20230 recalls

FDA records 5 decisions for 3M Healthcare Business Group (San Antonio, TX) from 2021 to 2023: 5 510(k) clearances. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 217 days from receipt to decision, against 238 for FDA’s reviews in the same codes and years. Its devices cite 6 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided 3M Healthcare Business Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 22022: 22023: 1
2021high 2 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — 3M Healthcare Business Group by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3M Healthcare Business Group’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?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump4decisions
  • FRODressing, Wound, Drug1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 217 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 238 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group · 20221cites it
  • K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac…3M Healthcare Business Group · 20211cites it
  • K2115213M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit…3M Healthcare Business Group · 20211cites it

What has FDA decided for it lately?

  • K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit3M Healthcare Business Group · 2023
  • K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group · 2022
  • K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group · 2022
  • K2115213M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit…3M Healthcare Business Group · 2021
  • K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac…3M Healthcare Business Group · 2021

All 5 as 3M Healthcare Business Group →