Applied Laboratories, Inc.: FDA clearances and approvals
Applied Laboratories, Inc. has 9 FDA 510(k) clearances (first 1985, latest 1988), across 3 product codes in 1 review panel. Median 510(k) review time: 185 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 |
|---|---|---|---|
| LRX | Case, Contact Lens | 6 | 6 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 2 | 2 |
| LPN | Accessories, Soft Lens Products | 1 | 1 |
Review panels
- Ophthalmic (9)
Most recent Applied Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873825 | GE LEXAN 144R 112 | LRX | 1988-03-24 | 185 |
| K873824 | RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 | LRX | 1988-03-24 | 185 |
| K873823 | MOBAY (BAYER) MAKROLON 2658 3291 | LRX | 1988-03-24 | 185 |
| K873822 | MOBAY (BAYER) MERLON M-40 (H)F 1112 | LRX | 1988-03-24 | 185 |
| K873821 | GE NORYL 731-80089S | LRX | 1988-03-24 | 185 |
| K873820 | MOBAY (BAYER) MAKROLON 2658 1112 | LRX | 1988-03-24 | 185 |
| K871714 | KESTREL CONTACT LENS CASE | LPN | 1987-05-26 | 22 |
| K860677 | EASY EYES TM LENS CARRYING CASE | HPX | 1986-05-29 | 93 |
| K853870 | EASY EYES TM LENS CARRYING CASE | HPX | 1985-12-10 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Applied Laboratories, 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 Applied Laboratories, Inc. have?
Applied Laboratories, Inc. has 9 FDA 510(k) clearances (first 1985, latest 1988), across 3 product codes in 1 review panel.
How long does FDA take to clear Applied Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Applied Laboratories, Inc.'s cleared 510(k)s is 185 days.
What devices does Applied Laboratories, Inc. make?
Its most frequent FDA product codes are LRX (Case, Contact Lens, 6); HPX (Lens, Contact (Polymethylmethacrylate), 2); LPN (Accessories, Soft Lens Products, 1).
Has Applied Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Applied Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 9 Applied Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRX, Applied Laboratories, 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.