Keilei Intl., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Keilei Intl., Inc.” (first 1989, latest 1991), across 4 product codes in 1 review panel. 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
Review panels
Most recent Keilei Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913779 | BANDAGE ROLL, GAUZE | NAB | 1991-12-04 | 112 |
| K912779 | GAUZE SPONGE,STERILE 2'S | NAB | 1991-09-30 | 98 |
| K913575 | GAUZE PACKING, SURGICAL STERILE AND NON-STERILE | FRO | 1991-09-06 | 25 |
| K895372 | X-RAY DETECTABLE GAUZE SPONGE | GDY | 1989-11-03 | 66 |
| K895086 | GAUZE SPONGE | EFQ | 1989-10-23 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Keilei Intl., Inc..
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 Keilei Intl., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Keilei Intl., Inc.” (first 1989, latest 1991), 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 Keilei Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Keilei Intl., Inc. is 76 days.
Which FDA product codes appear under Keilei Intl., Inc.?
The most frequent FDA product codes under this applicant name are NAB (Gauze / Sponge,Nonresorbable For External Use, 2); EFQ (Gauze/Sponge, Internal, 1); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 5 Keilei Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAB, Keilei Intl., Inc.'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.