Perlink USA, Inc.: FDA clearances and approvals
Perlink USA, Inc. has 6 FDA 510(k) clearances (first 1990, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time: 157 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 3 | 3 |
| EAM | Screen, Intensifying, Radiographic | 1 | 1 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
Review panels
- General Hospital (4)
- Radiology (2)
Most recent Perlink USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922358 | STERLING POWDER FREE PATIENT EXAMINATION GLOVES | LYY | 1993-06-11 | 388 |
| K924959 | STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC | LYY | 1993-03-03 | 154 |
| K921438 | DISPOSABLE LATEX EXAMINATION GLOVES | LYY | 1992-06-23 | 90 |
| K896707 | PERLINK SCREEN, KIRAN SCREEN | EAM | 1990-08-30 | 275 |
| K901790 | THERMOMETER, MERCURY/CLINICAL | FLK | 1990-07-11 | 83 |
| K896708 | PERLINK CASSETTE, KIRAN CASSETTE | IXA | 1990-05-07 | 160 |
Recalls
openFDA lists no recalls under a recalling firm named Perlink USA, 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 Perlink USA, Inc. have?
Perlink USA, Inc. has 6 FDA 510(k) clearances (first 1990, latest 1993), across 4 product codes in 2 review panels.
How long does FDA take to clear Perlink USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Perlink USA, Inc.'s cleared 510(k)s is 157 days.
What devices does Perlink USA, Inc. make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 3); EAM (Screen, Intensifying, Radiographic, 1); FLK (Thermometer, Clinical Mercury, 1).
Has Perlink USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Perlink USA, Inc. Related entities may recall under other names.
Next steps
- See all 6 Perlink USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Perlink USA, 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.