510(k) Report

FDA applicant

Johnson & Johnson Medical, Div. of Ethicon, Inc.

Arlington, TX5 decisions1998–19991 recall

FDA records 5 decisions for Johnson & Johnson Medical, Div. of Ethicon, Inc. (Arlington, TX) from 1998 to 1999: 5 510(k) clearances. Most are in product codes MGP (Dressing, Wound And Burn, Occlusive) and FYA (Gown, Surgical). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Johnson & Johnson Medical, Div. of Ethicon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Johnson & Johnson Medical, Div. of Ethicon, Inc. since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Johnson & Johnson Medical, Div. of Ethicon, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Johnson & Johnson Medical, Div. of…’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?

  • MGPDressing, Wound And Burn, Occlusive2decisions
  • FYAGown, Surgical1decision
  • KGOSurgeon'S Gloves1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

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 3 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.

  • K990236Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters, Optiva* I.V.…Johnson & Johnson Medical, Div. of Ethicon, Inc. · 19992cite it
  • K990395Barrier Surgical GownsJohnson & Johnson Medical, Div. of Ethicon, Inc. · 19991cites it

What has FDA decided for it lately?

  • K990236Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters, Optiva* I.V.…Johnson & Johnson Medical, Div. of Ethicon, Inc. · 19991 recall
  • K990395Barrier Surgical GownsJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1999
  • K983240Neutralon PF Powder Free Brown Latex Surgical GlovesJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998
  • K983234Tielle Plus Hydropolymer Adhesive DressingJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998
  • K983394Modification to Tielle Hydropolmer DressingJohnson & Johnson Medical, Div. of Ethicon, Inc. · 1998

All 5 as Johnson & Johnson Medical, Div. of Ethicon, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K990236ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner…Nov 26, 2018Class II

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 Patient Care, Inc. 4Johnson & Johnson Consumer Companies, Inc. 2Johnson and Johnson 2