Johnson & Johnson: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Johnson & Johnson” (first 2006, latest 2012), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 82 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 | 1 | 81 |
| 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 2 | 2 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
- Orthopedic (7)
- Neurology (2)
- General Hospital (1)
Most recent Johnson & Johnson 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113273 | SPOTLIGHT ACCESS SYSTEM | GZT | 2012-01-27 | 81 |
| K112913 | SPOTLIGHT ACCESS SYSTEM | GZT | 2011-12-16 | 74 |
| K113348 | COUGAR SYSTEM | MAX | 2011-12-13 | 29 |
| K110551 | EXPEDIUM SPINE SYSTEM | NKB | 2011-10-26 | 240 |
| K110694 | CONCORDE BULLET SPINAL SYSTEM | MAX | 2011-10-11 | 211 |
| K111571 | VIPER SYSTEMS | NKB | 2011-07-06 | 30 |
| K110454 | COUGAR LS LATERAL CAGE SYSTEM | MAX | 2011-05-13 | 86 |
| K103743 | CONCORDE CURVE SYSTEM | MAX | 2011-03-17 | 84 |
| K103490 | EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM | NKB | 2011-02-17 | 83 |
| K060618 | CIDEX ACTIVATED DIALDEHYDE SOLUTION | MED | 2006-04-12 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson.
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.
SEC filings
JOHNSON & JOHNSON (JNJ): EDGAR filings, CIK 200406. An SEC registrant with the same name, matched by name only.
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 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 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?
FDA lists 10 510(k) clearances under the applicant name “Johnson & Johnson” (first 2006, latest 2012), across 4 product codes in 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson is 82 days.
Which FDA product codes appear under Johnson & Johnson?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); NKB (Thoracolumbosacral Pedicle Screw System, 3); GZT (Retractor, Self-Retaining, For Neurosurgery, 2).
Next steps
- See all 10 Johnson & Johnson clearances with predicates and recalls
- Run predicate analysis for product code MAX, Johnson & Johnson'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.