510(k) Report

FDA applicant

Chesebrough-Pond'S U.S.A. Co.

Mchenry, IL33 decisions1976–19873 recalls

FDA records 33 decisions for Chesebrough-Pond'S U.S.A. Co. (Mchenry, IL) from 1976 to 1987: 33 510(k) clearances. Most are in product codes NAD (Dressing, Wound, Occlusive) and KNT (Tubes, Gastrointestinal (And Accessories)). 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, anesthesiology panel, where it files most

How often FDA has decided Chesebrough-Pond'S U.S.A. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chesebrough-Pond'S U.S.A. Co. since 2007.

Recalls per year

3in 2011

2011: 3
2007high 3 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Chesebrough-Pond'S U.S.A. Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chesebrough-Pond'S U.S.A. 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?

  • NADDressing, Wound, Occlusive5decisions
  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • BWFSpirometer, Therapeutic (Incentive)3decisions
  • FRODressing, Wound, Drug3decisions
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter3decisions
  • EFQGauze/Sponge, Internal2decisions

Also: KBG (1), EYQ (1), NAB (1), KXF (1), CAF (1), CBT (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K801199Voldyne Volumetric Incentive Deep BR. EXChesebrough-Pond'S U.S.A. Co. · 19801cites it
  • K851539Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 19851cites it

What has FDA decided for it lately?

  • K863866Respiradyne II (TM)Chesebrough-Pond'S U.S.A. Co. · 1987
  • K862803Chesebrough Pond's Hydrocolloid DressingChesebrough-Pond'S U.S.A. Co. · 1986
  • K851383Blisterfilm Transparent DressingChesebrough-Pond'S U.S.A. Co. · 1985
  • K851382Chesebrough-Pond's Sequential Wound DressingChesebrough-Pond'S U.S.A. Co. · 1985
  • K851539Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloChesebrough-Pond'S U.S.A. Co. · 1985
  • K843567Kangaroo Nasogastric Feeding TubeChesebrough-Pond'S U.S.A. Co. · 1985
  • K844186Continent Stoma System & AccessoriesChesebrough-Pond'S U.S.A. Co. · 1985
  • K845010Chesebrough-Pond's Uri-Drain Male Urinary PouchChesebrough-Pond'S U.S.A. Co. · 1985

All 33 as Chesebrough-Pond'S U.S.A. Co. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K770789URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin…Apr 29, 2011
  • K770789URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in Canada…Apr 29, 2011
  • K770789URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin…Apr 29, 2011