Cush Medical Products: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Cush Medical Products” (first 1994, latest 1994), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 6 | 6 |
| LRO | General Surgery Tray | 5 | 5 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 2 | 2 |
| LRP | Tray, Surgical | 2 | 2 |
| MLS | Labor And Delivery Kit | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| HFX | Clamp, Circumcision | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Cush Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943424 | CUSH ISLAND DRESSING | MGP | 1994-10-03 | 80 |
| K940518 | C-SECTION TRAY | MLS | 1994-08-18 | 195 |
| K941349 | DENTAL TRAY | EIA | 1994-07-26 | 127 |
| K941645 | BIOPSY TRAY | FRG | 1994-07-14 | 101 |
| K940239 | EYE TRAY | LRP | 1994-06-28 | 160 |
| K935684 | IV START KIT | LRS | 1994-06-10 | 193 |
| K941455 | STERILE GAUZE PRODUCT LINE | EFQ | 1994-05-20 | 56 |
| K941522 | STERILE X-RAY DETECTABLE GAUZE SPONGES | GDY | 1994-05-12 | 43 |
| K941344 | LAP SPONGE PRODUCT LINE | GDY | 1994-05-12 | 56 |
| K935697 | CIRCUMCISION TRAY | HFX | 1994-05-02 | 153 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cush Medical Products.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cush Industries, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cush Medical Products?
FDA lists 23 510(k) clearances under the applicant name “Cush Medical Products” (first 1994, latest 1994), across 11 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 Cush Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cush Medical Products is 76 days.
Which FDA product codes appear under Cush Medical Products?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 6); LRO (General Surgery Tray, 5); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 2).
Next steps
- See all 23 Cush Medical Products clearances with predicates and recalls
- Run predicate analysis for product code FRG, Cush Medical Products'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.