Johnson & Johnson Medical, Inc.: FDA clearances and approvals
Johnson & Johnson Medical, Inc. has 56 FDA 510(k) clearances (first 1990, latest 2004), across 34 product codes in 5 review panels. Median 510(k) review time: 157 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 10 | 10 |
| FXX | Mask, Surgical | 3 | 3 |
| HHW | Pessary, Vaginal | 3 | 3 |
| LYY | Latex Patient Examination Glove | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| FYA | Gown, Surgical | 2 | 2 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
Plus 24 more product codes.
Review panels
- General Hospital (31)
- General and Plastic Surgery (14)
- Cardiovascular (7)
- Obstetrics and Gynecology (3)
- Gastroenterology and Urology (1)
Most recent Johnson & Johnson Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033523 | COLLAGEN-ORC ANTIMICROBIAL MATRIX | FRO | 2004-10-21 | 349 |
| K022483 | ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING | FRO | 2003-02-03 | 189 |
| K014129 | PROMOGRAN MATRIX WOUND DRESSING | KGN | 2002-02-14 | 59 |
| K001690 | PROTECTIV SAFETY BLOOD COLLECTION NEEDLE | FMI | 2000-07-31 | 59 |
| K982641 | ADVANCED NIBP MODULE | DXN | 1999-03-29 | 243 |
| K983362 | NU-GEL * WOUND DRESSING | MGQ | 1998-12-16 | 83 |
| K982597 | FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE | KGN | 1998-08-20 | 27 |
| K974080 | CRITIKON SOFT BLOOD PRESSURE CUFF | DXQ | 1998-05-18 | 201 |
| K980493 | I.V. CATHETER SYSTEM | FOZ | 1998-04-28 | 78 |
| K972498 | OBSERVER * CENTRAL STATION | DSI | 1998-02-17 | 229 |
46 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Johnson & Johnson Medical, Inc. have?
Johnson & Johnson Medical, Inc. has 56 FDA 510(k) clearances (first 1990, latest 2004), across 34 product codes in 5 review panels.
How long does FDA take to clear Johnson & Johnson Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Johnson & Johnson Medical, Inc.'s cleared 510(k)s is 157 days.
What devices does Johnson & Johnson Medical, Inc. make?
Its most frequent FDA product codes are KGO (Surgeon'S Gloves, 10); FXX (Mask, Surgical, 3); HHW (Pessary, Vaginal, 3).
Has Johnson & Johnson Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Johnson & Johnson Medical, Inc. Related entities may recall under other names.
Next steps
- See all 56 Johnson & Johnson Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Johnson & Johnson Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.