510(k) Report

FDA applicant

Johnson & Johnson Consumer Companies, Inc.

Skillman, NJ2 decisions2000–20060 recalls

FDA records 2 decisions for Johnson & Johnson Consumer Companies, Inc. (Skillman, NJ) from 2000 to 2006: 2 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and SEJ (Wound Dressings Containing Topical Analgesics). Its devices cite 2 predicates, 0 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 hospital panel, where it files most

How often FDA has decided Johnson & Johnson Consumer Companies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Johnson & Johnson Consumer Companies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Johnson & Johnson Consumer Companies, Inc. 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?

  • KMFBandage, Liquid1decision
  • SEJWound Dressings Containing Topical Analgesics1decision

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 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.

  • K062602Band-Aid (R) Brand Liquid BandageJohnson & Johnson Consumer Companies, Inc. · 20061cites it

What has FDA decided for it lately?

  • K062602Band-Aid (R) Brand Liquid BandageJohnson & Johnson Consumer Companies, Inc. · 2006
  • K001023Freedom, Model 4660Johnson & Johnson Consumer Companies, Inc. · 2000

All 2 as Johnson & Johnson Consumer Companies, Inc. →

Other applicant names beginning “Johnson”

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

Johnson & Johnson Professionals, Inc. 206Johnson & Johnson Medical, Inc. 56Johnson & Johnson Clinical Diagnostics, Inc. 33Johnson & Johnson Orthopaedics, Inc. 22Johnson & Johnson Vision Care, Inc. 13Johnson & Johnson 12Johnson & Johnson Surgical Vision, Inc. 11Johnson & Johnson International 10Johnson & Johnson Consumer Products, Inc. 8Johnson & Johnson Medical, Div. of Ethicon, Inc. 5Johnson & Johnson Patient Care, Inc. 4Johnson and Johnson 2