Johnson & Johnson Professionals, Inc.: FDA clearances and approvals
Johnson & Johnson Professionals, Inc. has 206 FDA 510(k) clearances (first 1976, latest 2000), across 85 product codes in 12 review panels. Median 510(k) review time: 59 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 15 | 15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 14 | 14 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 9 | 9 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 9 | 9 |
| FPX | Strip, Adhesive, Closure, Skin | 7 | 7 |
| JXG | Shunt, Central Nervous System And Components | 7 | 7 |
| FRO | Dressing, Wound, Drug | 6 | 6 |
| KGX | Tape And Bandage, Adhesive | 6 | 6 |
| EXB | Collector, Ostomy | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
Plus 75 more product codes.
Review panels
- Orthopedic (60)
- Dental (50)
- General and Plastic Surgery (33)
- Neurology (14)
- Cardiovascular (9)
- Gastroenterology and Urology (9)
- General Hospital (9)
- Radiology (8)
- Obstetrics and Gynecology (6)
- Physical Medicine (4)
- Clinical Chemistry (1)
- Hematology (1)
Most recent Johnson & Johnson Professionals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | JXG | 2000-04-07 | 284 |
| K991413 | CODMAN ETHISORB DURA PATCH | GXQ | 2000-03-13 | 325 |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | GWM | 1999-07-09 | 88 |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | HCI | 1998-12-18 | 163 |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | KWY | 1998-12-04 | 115 |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | JDB | 1998-11-06 | 59 |
| K983014 | SUMMIT ACETABULAR SYSTEM | LPH | 1998-10-27 | 60 |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | JXG | 1998-07-17 | 137 |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | JXG | 1998-07-01 | 194 |
| K980801 | J-FX BIPOLAR HEAD | KWY | 1998-05-29 | 88 |
196 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson Professionals, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Johnson & Johnson Professionals, Inc.'s product codes (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances does Johnson & Johnson Professionals, Inc. have?
Johnson & Johnson Professionals, Inc. has 206 FDA 510(k) clearances (first 1976, latest 2000), across 85 product codes in 12 review panels.
How long does FDA take to clear Johnson & Johnson Professionals, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Johnson & Johnson Professionals, Inc.'s cleared 510(k)s is 59 days.
What devices does Johnson & Johnson Professionals, Inc. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 15); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 14); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 9).
Has Johnson & Johnson Professionals, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Johnson & Johnson Professionals, Inc. Related entities may recall under other names.
Next steps
- See all 206 Johnson & Johnson Professionals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Johnson & Johnson Professionals, 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.