Spiration, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spiration, Inc.” (first 2015, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 143 days. Since 2017 the median was 143 days, against 122 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 |
|---|---|---|
| 2015 | 1 | 200 |
| 2016 | 1 | 140 |
| 2017 | 3 | 143 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spiration, Inc. took a median 143 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KTI | Bronchoscope Accessory | 1 | 1 |
Review panels
Most recent Spiration, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171492 | B7 2C Occlusion Balloon | EOQ | 2017-11-20 | 182 |
| K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator | GEI | 2017-05-11 | 38 |
| K162611 | PeriFLEX | EOQ | 2017-02-09 | 143 |
| K152922 | ViziShot FLEX | KTI | 2016-02-19 | 140 |
| K142909 | Flexible 19G EBUS Needle | EOQ | 2015-04-24 | 200 |
Recalls
openFDA lists no recalls under a recalling firm named Spiration, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Spiration, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Spiration, Inc.” (first 2015, latest 2017), across 3 product codes in 2 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 Spiration, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spiration, Inc. is 143 days. Since 2017: 143 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spiration, Inc.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); KTI (Bronchoscope Accessory, 1).
Next steps
- See all 5 Spiration, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Spiration, 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, 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.