Janin Group, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Janin Group, Inc.” (first 1981, latest 2002), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 4 | 4 |
| KQM | Camera, Surgical And Accessories | 1 | 1 |
Review panels
Most recent Janin Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012502 | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | FJS | 2002-02-04 | 185 |
| K013017 | MEDIGROUP KEY TUBE | FJS | 2001-12-06 | 90 |
| K991042 | ASH ADVANTAGE PERITONEAL CATHETER | FJS | 1999-06-25 | 88 |
| K970159 | FLEX-NECK PD CATHETER | FJS | 1997-09-05 | 232 |
| K810512 | MEDISEAL CAMERA COVERS | KQM | 1981-03-13 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Janin Group, 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 Janin Group, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Janin Group, Inc.” (first 1981, latest 2002), across 2 product codes in 2 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 Janin Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Janin Group, Inc. is 90 days.
Which FDA product codes appear under Janin Group, Inc.?
The most frequent FDA product codes under this applicant name are FJS (Catheter, Peritoneal, Long-Term Indwelling, 4); KQM (Camera, Surgical And Accessories, 1).
Next steps
- See all 5 Janin Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FJS, Janin Group, 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.