Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spiration, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
200 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171492 | B7 2C Occlusion Balloon | Spiration, Inc. | 2017-11-20 | 182 | 0 |
| K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Ap | Spiration, Inc. | 2017-05-11 | 38 | 0 |
| K162611 | PeriFLEX | Spiration, Inc. | 2017-02-09 | 143 | 0 |
| K152922 | ViziShot FLEX | Spiration, Inc. | 2016-02-19 | 140 | 0 |
| K142909 | Flexible 19G EBUS Needle | Spiration, Inc. | 2015-04-24 | 200 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda