510(k) Report

FDA applicant

Wrapped IN Comfort

San Lorenzo, CA2 decisions2004–20050 recalls

FDA records 2 decisions for Wrapped IN Comfort (San Lorenzo, CA) from 2004 to 2005: 2 510(k) clearances. All are in product code MMP (Cover, Barrier, Protective). 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 Wrapped IN Comfort’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wrapped IN Comfort since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wrapped IN Comfort by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MMPCover, Barrier, Protective2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K043234Light DrapeWrapped IN Comfort · 20051cites it

What has FDA decided for it lately?

  • K043234Light DrapeWrapped IN Comfort · 2005
  • K040794Incubator CapeWrapped IN Comfort · 2004

All 2 as Wrapped IN Comfort →