Olympus Corp.: FDA filings under this applicant name
FDA lists 149 510(k) clearances under 3 spellings of the applicant name “Olympus Corp.” (first 1978, latest 2007), across 86 product codes in 14 review panels. Median 510(k) review time under this name: 88 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 | 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 6 | 6 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 6 | 6 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 5 | 5 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 5 | 5 |
| CIG | Diazo Colorimetry, Bilirubin | 4 | 4 |
| HIH | Hysteroscope (And Accessories) | 4 | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 | 3 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 3 | 3 |
| EWY | Mediastinoscope, Surgical | 3 | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 3 |
Plus 76 more product codes.
Review panels
- Clinical Chemistry (70)
- Gastroenterology and Urology (36)
- Cardiovascular (9)
- Ear, Nose and Throat (8)
- Obstetrics and Gynecology (6)
- General and Plastic Surgery (5)
- Radiology (4)
- Anesthesiology (2)
- General Hospital (2)
- Microbiology (2)
- Dental (1)
- Hematology (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Olympus Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072643 | CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US | KZN | 2007-11-16 | 59 |
| K043128 | OLYMPUS ENDOARM | GWG | 2004-12-21 | 39 |
| K042140 | OLYMPUS BF TYPE UC160-OL8 | ODG | 2004-08-18 | 9 |
| K041494 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 | FET | 2004-07-01 | 27 |
| K040940 | BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM | EOQ | 2004-04-19 | 7 |
| K915402 | EW-10 AND EW-20 | FEB | 1995-06-23 | 1297 |
| K933200 | OLYMPUS PBD STENTS | FGE | 1995-04-05 | 643 |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | FDT | 1994-11-30 | 198 |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | FAS | 1994-08-29 | 508 |
| K934835 | FLOVAL | FJL | 1994-06-21 | 256 |
139 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Olympus Corp..
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.
Device clinical trials
An industry sponsor named Olympus Corp. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01753479: Spectroscopy From Duodenum (Completed, started 2013-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Olympus Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via DQI)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via DQI)
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Olympus Corp. (142)
- Olympus Corporation (5)
- Olympus (2)
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 America, Inc. (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 Corp.?
FDA lists 149 510(k) clearances under 3 spellings of the applicant name “Olympus Corp.” (first 1978, latest 2007), across 86 product codes in 14 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 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Olympus Corp. is 88 days.
Which FDA product codes appear under Olympus Corp.?
The most frequent FDA product codes under this applicant name are CGX (Alkaline Picrate, Colorimetry, Creatinine, 6); CHJ (Mercuric Thiocyanate, Colorimetry, Chloride, 6); EOQ (Bronchoscope (Flexible Or Rigid), 5).
Next steps
- See all 149 Olympus Corp. clearances with predicates and recalls
- Run predicate analysis for product code CGX, Olympus Corp.'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.