Ansley Medical Products, Inc.: FDA clearances and approvals
Ansley Medical Products, Inc. has 5 FDA 510(k) clearances (first 1992, latest 1993), across 3 product codes in 1 review panel. Median 510(k) review time: 75 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 |
|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Ansley Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932857 | ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC. | KKX | 1993-09-13 | 95 |
| K925290 | CATALOG NUMBER 111 (FACESHIELD) | LYU | 1993-07-23 | 275 |
| K924568 | TUBE, LEAD, AND CORD HOLDER NO. 102 | KMK | 1992-11-23 | 75 |
| K924567 | FOLEY CATHETER TUBE HOLDER NO. 101 | KMK | 1992-11-23 | 75 |
| K924566 | RESTRAINT, PROTECTIVE N0. 103 | KMK | 1992-11-23 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Ansley Medical Products, 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 Ansley Medical Products, Inc. have?
Ansley Medical Products, Inc. has 5 FDA 510(k) clearances (first 1992, latest 1993), across 3 product codes in 1 review panel.
How long does FDA take to clear Ansley Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ansley Medical Products, Inc.'s cleared 510(k)s is 75 days.
What devices does Ansley Medical Products, Inc. make?
Its most frequent FDA product codes are KMK (Device, Intravascular Catheter Securement, 3); KKX (Drape, Surgical, Antimicrobial, 1); LYU (Accessory, Surgical Apparel, 1).
Has Ansley Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ansley Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 5 Ansley Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMK, Ansley Medical Products, 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.