Olympus America, Inc.: FDA filings under this applicant name
FDA lists 149 510(k) clearances under the applicant name “Olympus America, Inc.” (first 1994, latest 2012), across 72 product codes in 13 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Olympus, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 203 |
| 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 10 | 10 |
| GCJ | Laparoscope, General & Plastic Surgery | 10 | 10 |
| HET | Laparoscope, Gynecologic (And Accessories) | 8 | 8 |
| ITX | Transducer, Ultrasonic, Diagnostic | 8 | 8 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| JIT | Calibrator, Secondary | 4 | 4 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 4 | 4 |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 3 | 3 |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 3 | 3 |
Plus 62 more product codes.
Review panels
- Gastroenterology and Urology (41)
- Clinical Chemistry (33)
- Immunology (19)
- General and Plastic Surgery (14)
- Ear, Nose and Throat (13)
- Obstetrics and Gynecology (12)
- Radiology (10)
- Orthopedic (2)
- Anesthesiology (1)
- Hematology (1)
- General Hospital (1)
- Microbiology (1)
- Clinical Toxicology (1)
Most recent Olympus America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111788 | ENDOEYE HD II | HET | 2012-01-13 | 203 |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | DHX | 2009-03-18 | 282 |
| K073490 | OLYMPUS IGG REAGENT | CFN | 2008-02-11 | 61 |
| K073489 | OLYMPUS IGA REAGENT | CFN | 2008-02-11 | 61 |
| K073487 | OLYMPUS IGM REAGENT | CFN | 2008-02-11 | 61 |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | KNK | 2007-04-06 | 193 |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | CDT | 2007-03-23 | 91 |
| K061499 | OSFERION | MQV | 2007-01-26 | 240 |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | JLW | 2006-11-29 | 90 |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | CJY | 2006-10-05 | 120 |
139 earlier clearances. See the full list in Caduvo.
Recalls
21 product recalls in 17 recall events; 0 initiated in the last five years. Most recent: 2015-03-26.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Olympus Medical Systems Corp. (190 510(k)s)
- Olympus Corp. (149 510(k)s)
- Olympus Winter & Ibe GmbH (43 510(k)s)
- The Olympus Optical Co. (26 510(k)s)
- Olympus Optical Co., Ltd. (22 510(k)s)
- Olympus Surgical Technologies America (14 510(k)s)
- Olympus Diagnostica GmbH (4 510(k)s)
- Olympus Life & Material Science Europa GmbH (Irish (3 510(k)s)
- Olympus Life Science Research Europa GmbH (Europa) (3 510(k)s)
- Olympus Terumo Biomaterials Corporation (3 510(k)s)
- Olympus Corp of America (2 510(k)s)
- Olympus Opto-Electronics Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Olympus America, Inc.?
FDA lists 149 510(k) clearances under the applicant name “Olympus America, Inc.” (first 1994, latest 2012), across 72 product codes in 13 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Olympus America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Olympus America, Inc. is 84 days.
Which FDA product codes appear under Olympus America, Inc.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 10); GCJ (Laparoscope, General & Plastic Surgery, 10); HET (Laparoscope, Gynecologic (And Accessories), 8).
Next steps
- See all 149 Olympus America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Olympus America, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.