Johnson & Johnson Consumer Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Johnson & Johnson Consumer Products, Inc.” (first 1984, latest 2007), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | 4 | 4 |
| JES | Floss, Dental | 2 | 2 |
| EYQ | Garment, Protective, For Incontinence | 1 | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 | 1 |
Review panels
Most recent Johnson & Johnson Consumer Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | IMD | 2007-08-14 | 53 |
| K943314 | ADHESIVE BANDAGES WITH OTC DRUG | KGX | 1996-01-17 | 555 |
| K954007 | PARALLEL | KGX | 1995-11-22 | 89 |
| K951917 | JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS | JES | 1995-05-10 | 16 |
| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | KGX | 1994-10-03 | 175 |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | KGX | 1994-10-03 | 238 |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | JES | 1994-02-03 | 83 |
| K840679 | SERENITY CONTOURED ABSORBENT SHIELDS | EYQ | 1984-03-22 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson Consumer Products, 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 Medical, Inc. (56 510(k)s)
- Johnson & Johnson Clinical Diagnostics, Inc. (33 510(k)s)
- Johnson & Johnson Orthopaedics, Inc. (22 510(k)s)
- Johnson & Johnson Vision Care, Inc. (12 510(k)s)
- Johnson & Johnson (10 510(k)s)
- Johnson & Johnson International (10 510(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 and Johnson (2 510(k)s)
- Johnson & Johnson Company (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Johnson & Johnson Consumer Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Johnson & Johnson Consumer Products, Inc.” (first 1984, latest 2007), across 4 product codes in 4 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 Consumer Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Consumer Products, Inc. is 86 days.
Which FDA product codes appear under Johnson & Johnson Consumer Products, Inc.?
The most frequent FDA product codes under this applicant name are KGX (Tape And Bandage, Adhesive, 4); JES (Floss, Dental, 2); EYQ (Garment, Protective, For Incontinence, 1).
Next steps
- See all 8 Johnson & Johnson Consumer Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGX, Johnson & Johnson Consumer Products, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.