Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CBR · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
117 daysmedian FDA review time
214 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112173 | SPEACELABS MULTIGAS MODULE | Spacelabs Healthcare | 2011-10-05 | 69 | 1 |
| K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSO | Spacelabs Medical, Inc. | 2006-04-19 | 117 | 2 |
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | Spacelabs, Inc. | 1996-05-31 | 214 | 0 |
| K904843 | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | Dalton Instrument Corp. | 1991-04-09 | 166 | 0 |
| K853360 | N20 TEST | Erich Jaeger, Inc. | 1985-09-03 | 22 | 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