Jeff Klein Surgical, Inc.: FDA clearances and approvals
Jeff Klein Surgical, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time: 39 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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | 3 | 3 |
| GCE | Adaptor, Catheter | 2 | 2 |
Review panels
Most recent Jeff Klein Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901718 | KLEIN LAMPREY-CANNULA(TM) | GEA | 1990-05-24 | 41 |
| K901717 | KLEIN MICRO-CANNULA(TM) | GEA | 1990-05-24 | 41 |
| K901719 | KLEIN MICRO-CANNULA HANDLE(TM) | GEA | 1990-05-22 | 39 |
| K901716 | KLEIN CONNECTOR(TM) | GCE | 1990-05-11 | 28 |
| K901715 | KLEIN CORK(TM) | GCE | 1990-05-11 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Jeff Klein Surgical, 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.
Frequently asked questions
How many FDA 510(k) clearances does Jeff Klein Surgical, Inc. have?
Jeff Klein Surgical, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1990), across 2 product codes in 1 review panel.
How long does FDA take to clear Jeff Klein Surgical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Jeff Klein Surgical, Inc.'s cleared 510(k)s is 39 days.
What devices does Jeff Klein Surgical, Inc. make?
Its most frequent FDA product codes are GEA (Cannula, Surgical, General & Plastic Surgery, 3); GCE (Adaptor, Catheter, 2).
Has Jeff Klein Surgical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jeff Klein Surgical, Inc. Related entities may recall under other names.
Next steps
- See all 5 Jeff Klein Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEA, Jeff Klein Surgical, 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.