Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spiracle Technology — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982225 | SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL | Spiracle Technology | 1998-10-28 | 126 | 0 |
| K973347 | TSX PRM PULMONARY RESUSCITATION MONITOR | Spiracle Technology | 1998-07-23 | 321 | 0 |
| K963755 | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR | Spiracle Technology | 1997-04-08 | 202 | 0 |
| K953349 | SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE | Spiracle Technology | 1996-02-29 | 227 | 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