Olympus Surgical Technologies America: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Olympus Surgical Technologies America” (first 2012, latest 2026), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 76 days, against 103 days for all cleared 510(k)s in the same product codes. 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 | 49 |
| 2013 | 2 | 108 |
| 2014 | 0 | — |
| 2015 | 1 | 98 |
| 2016 | 0 | — |
| 2017 | 2 | 131 |
| 2018 | 1 | 60 |
| 2019 | 2 | 144 |
| 2020 | 1 | 90 |
| 2021 | 1 | 38 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 2 | 66 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Olympus Surgical Technologies America took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| KTI | Bronchoscope Accessory | 4 | 4 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent Olympus Surgical Technologies America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262877 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | 2026-09-16 | 30 |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | 2026-07-24 | 101 |
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | GEX | 2024-08-23 | 29 |
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | 2021-09-27 | 38 |
| K193517 | ViziShot 2 FLEX | KTI | 2020-03-18 | 90 |
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories) | GEX | 2019-08-09 | 226 |
| K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | ODC | 2019-04-04 | 63 |
| K181193 | PeriView FLEX | KTI | 2018-07-03 | 60 |
| K171232 | PeriView FLEX | KTI | 2017-09-21 | 147 |
| K163469 | ViziShot 2 FLEX | KTI | 2017-04-06 | 115 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Olympus Surgical Technologies America.
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 America, Inc. (149 510(k)s)
- Olympus Winter & Ibe GmbH (43 510(k)s)
- Olympus Optical Co., Ltd. (26 510(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)
- Olympus America Inc. / Scientific Equipment Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Olympus Surgical Technologies America?
FDA lists 14 510(k) clearances under the applicant name “Olympus Surgical Technologies America” (first 2012, latest 2026), across 8 product codes in 3 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 Surgical Technologies America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Olympus Surgical Technologies America is 94 days. Since 2017: 76 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Olympus Surgical Technologies America?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); KTI (Bronchoscope Accessory, 4); EZN (Dilator, Catheter, Ureteral, 1).
Next steps
- See all 14 Olympus Surgical Technologies America clearances with predicates and recalls
- Run predicate analysis for product code GEX, Olympus Surgical Technologies America'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.