Johnson & Johnson Medical, Inc.: FDA filings under this applicant name
FDA lists 53 510(k) clearances under the applicant name “Johnson & Johnson Medical, Inc.” (first 1990, latest 2000), across 33 product codes in 5 review panels. Median 510(k) review time under this name: 154 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
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 |
| FYA | Gown, Surgical | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| LRJ | Disinfectant, Medical Devices | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
Plus 23 more product codes.
Review panels
- General Hospital (31)
- General and Plastic Surgery (11)
- 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 |
|---|---|---|---|---|
| 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 |
| K973699 | ULTRALON POWDER FREE LATEX SURGICAL GLOVE | KGO | 1997-12-16 | 78 |
| K971569 | DINAMAP MPS PORTABLE MONITOR | MSX | 1997-09-19 | 143 |
| K970182 | DINAMAP COMPACT MONITOR | MHX | 1997-08-18 | 213 |
43 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Johnson & Johnson Professionals, Inc. (206 510(k)s)
- Johnson & Johnson Clinical Diagnostics, Inc. (33 510(k)s)
- Johnson & Johnson Orthopaedics, Inc. (22 510(k)s)
- Johnson & Johnson (14 510(k)s)
- Johnson & Johnson Vision Care, Inc. (12 510(k)s)
- Johnson & Johnson International (10 510(k)s)
- Johnson & Johnson Consumer Products, Inc. (8 510(k)s)
- Johnson & Johnson Medical, Div. of Ethicon, Inc. (5 510(k)s)
- Johnson & Johnson Surgical Vision, Inc. (4 510(k)s)
- Johnson & Johnson Patient Care, Inc. (4 510(k)s)
- Johnson & Johnson Medical, Ltd. (3 510(k)s)
- Johnson & Johnson Consumer, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Johnson & Johnson Medical, Inc.?
FDA lists 53 510(k) clearances under the applicant name “Johnson & Johnson Medical, Inc.” (first 1990, latest 2000), across 33 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Johnson & Johnson Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Medical, Inc. is 154 days.
Which FDA product codes appear under Johnson & Johnson Medical, Inc.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 10); FXX (Mask, Surgical, 3); HHW (Pessary, Vaginal, 3).
Next steps
- See all 53 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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.