Ascep, Inc.: FDA clearances and approvals
Ascep, Inc. has 9 FDA 510(k) clearances (first 1979, latest 1983), across 5 product codes in 2 review panels. Median 510(k) review time: 36 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | 4 | 4 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| GDX | Scalpel, One-Piece | 1 | 1 |
| HAO | Instrument, Surgical, Non-Powered | 1 | 1 |
Review panels
Most recent Ascep, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830219 | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS | FSM | 1983-04-12 | 78 |
| K822893 | G.E.V. DISPOSABLE SCALPELS | GDX | 1982-10-22 | 24 |
| K810004 | STERILE DISPOSABLE INSTRUMENT TRAYS | FSM | 1981-01-26 | 20 |
| K802726 | INSTRUMENTS NONSTERILE & STERILE | HAO | 1980-11-19 | 23 |
| K791886 | I.V. CARE KIT | KGX | 1979-10-26 | 45 |
| K791885 | I.V. START SET | KGX | 1979-10-22 | 41 |
| K791889 | SUTURE REMOVAL TRAY, REORDER 7950&7951 | FSM | 1979-10-17 | 36 |
| K791888 | CATHETER CARE KIT REORDER 7940&7941 | EFQ | 1979-10-17 | 36 |
| K791887 | CENTRAL VENOUS CATHETER DRESSING TRAY | FSM | 1979-10-17 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Ascep, 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 Ascep, Inc. have?
Ascep, Inc. has 9 FDA 510(k) clearances (first 1979, latest 1983), across 5 product codes in 2 review panels.
How long does FDA take to clear Ascep, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ascep, Inc.'s cleared 510(k)s is 36 days.
What devices does Ascep, Inc. make?
Its most frequent FDA product codes are FSM (Tray, Surgical, Instrument, 4); KGX (Tape And Bandage, Adhesive, 2); EFQ (Gauze/Sponge, Internal, 1).
Has Ascep, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ascep, Inc. Related entities may recall under other names.
Next steps
- See all 9 Ascep, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FSM, Ascep, 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.