Carl Parker Associates, Inc.: FDA clearances and approvals
Carl Parker Associates, Inc. has 7 FDA 510(k) clearances (first 1987, latest 1997), across 4 product codes in 1 review panel. Median 510(k) review time: 91 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 |
|---|---|---|---|
| FXX | Mask, Surgical | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Carl Parker Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971130 | DEFEND FLUID RESISTANT PLEATED MASK | FXX | 1997-06-27 | 92 |
| K962654 | COMPLEAT SURGICAL MASK | FXX | 1997-01-27 | 203 |
| K932056 | DEFEND SELF-SEALING STERILIZATION POUCH | KCT | 1994-07-13 | 441 |
| K891308 | STERILE SURGICAL GLOVES | KGO | 1989-04-26 | 48 |
| K891257 | DEFEND LATEX EXAMINATION GLOVES | LYY | 1989-03-22 | 14 |
| K891157 | DEFEND LATEX EXAMINATION GLOVES | LYY | 1989-03-16 | 10 |
| K871558 | DENTAL FACE MASKS, POLYESTER | FXX | 1987-07-22 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Carl Parker Associates, 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 Carl Parker Associates, Inc. have?
Carl Parker Associates, Inc. has 7 FDA 510(k) clearances (first 1987, latest 1997), across 4 product codes in 1 review panel.
How long does FDA take to clear Carl Parker Associates, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Carl Parker Associates, Inc.'s cleared 510(k)s is 91 days.
What devices does Carl Parker Associates, Inc. make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 3); LYY (Latex Patient Examination Glove, 2); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1).
Has Carl Parker Associates, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Carl Parker Associates, Inc. Related entities may recall under other names.
Next steps
- See all 7 Carl Parker Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Carl Parker Associates, 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.