Carwild Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Carwild Corp.” (first 1979, latest 1992), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 133 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 2 | 2 |
| GDI | Dissector, Surgical, General & Plastic Surgery | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Review panels
Most recent Carwild Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913303 | LAP SPONGES, MODIFIED | GDY | 1992-08-06 | 378 |
| K913302 | DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED | GDY | 1992-07-23 | 364 |
| K833688 | SUTURE REMOVAL KITS STERILE | KGX | 1984-05-31 | 213 |
| K791872 | LAP SPONGES | EFQ | 1979-11-13 | 53 |
| K791871 | NEUROLOGICAL SPONGES (PATTIES) | EFQ | 1979-11-05 | 45 |
| K791870 | DISPOSABLE SPECIALITY SPONGES | GDI | 1979-11-05 | 45 |
Recalls
4 product recalls in 2 recall events; 4 initiated in the last five years. Most recent: 2024-10-22.
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 Carwild Corp.?
FDA lists 6 510(k) clearances under the applicant name “Carwild Corp.” (first 1979, latest 1992), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carwild Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carwild Corp. is 133 days.
Which FDA product codes appear under Carwild Corp.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 2); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 2); GDI (Dissector, Surgical, General & Plastic Surgery, 1).
Next steps
- See all 6 Carwild Corp. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Carwild Corp.'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.