J.J. Skinner, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “J.J. Skinner, Inc.” (first 1990, latest 1996), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 99 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 |
|---|---|---|---|
| LRO | General Surgery Tray | 2 | 2 |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| GJE | Tray, Blood Collection | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- General Hospital (2)
- Clinical Chemistry (1)
- Gastroenterology and Urology (1)
Most recent J.J. Skinner, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961227 | JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY | FRG | 1996-06-10 | 74 |
| K961683 | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY | LRO | 1996-05-10 | 9 |
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | FKG | 1995-05-03 | 916 |
| K925467 | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT | LRO | 1994-05-11 | 559 |
| K925468 | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | GJE | 1994-04-11 | 529 |
| K903545 | CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS | FOZ | 1990-11-13 | 99 |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | LRP | 1990-08-31 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named J.J. Skinner, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under J.J. Skinner, Inc.?
FDA lists 7 510(k) clearances under the applicant name “J.J. Skinner, Inc.” (first 1990, latest 1996), across 6 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 J.J. Skinner, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J.J. Skinner, Inc. is 99 days.
Which FDA product codes appear under J.J. Skinner, Inc.?
The most frequent FDA product codes under this applicant name are LRO (General Surgery Tray, 2); FKG (Tray, Start/Stop (Including Contents), Dialysis, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 7 J.J. Skinner, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRO, J.J. Skinner, 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.