American Optical Corp.: FDA clearances and approvals
American Optical Corp. has 35 FDA 510(k) clearances (first 1976, latest 1995), across 20 product codes in 7 review panels. Median 510(k) review time: 28 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 5 | 5 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 4 | 4 |
| CAL | Laryngoscope, Non-Rigid | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| HKO | Refractometer, Ophthalmic | 3 | 3 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Plus 10 more product codes.
Review panels
- Ophthalmic (18)
- Gastroenterology and Urology (6)
- Anesthesiology (4)
- Cardiovascular (4)
- Clinical Chemistry (1)
- Ear, Nose and Throat (1)
- Pathology (1)
Most recent American Optical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950881 | PHACO TIP | HQC | 1995-09-06 | 191 |
| K950880 | AOI UNIVERSAL ULTRASONIC HANDPIECE | HQC | 1995-05-26 | 88 |
| K931358 | AORP4000 REUSABLE PAK | HQC | 1994-02-22 | 342 |
| K931354 | P4000 PHACOEMULSIFIER | HQC | 1994-02-22 | 342 |
| K931357 | AOD4000 DISPOSABLE PAK | HQC | 1994-01-25 | 314 |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | FAM | 1982-04-01 | 9 |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | IDL | 1981-12-29 | 21 |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | FAM | 1981-11-02 | 11 |
| K812051 | PHOTOLITE AOLITE TINTOMATIC LENS | HQG | 1981-09-08 | 49 |
| K812063 | SR-1V DATA PRINTER | HKO | 1981-08-18 | 28 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Optical Corp..
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 American Optical Corp. have?
American Optical Corp. has 35 FDA 510(k) clearances (first 1976, latest 1995), across 20 product codes in 7 review panels.
How long does FDA take to clear American Optical Corp.'s 510(k)s?
The median time from FDA receipt to decision across American Optical Corp.'s cleared 510(k)s is 28 days.
What devices does American Optical Corp. make?
Its most frequent FDA product codes are HQC (Unit, Phacofragmentation, 5); HQG (Lens, Spectacle, Non-Custom (Prescription), 4); CAL (Laryngoscope, Non-Rigid, 3).
Has American Optical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Optical Corp. Related entities may recall under other names.
Next steps
- See all 35 American Optical Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQC, American Optical Corp.'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.