Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Minesafety Appliances Co. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
192 daysmedian FDA review time
271 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961644 | MINIOX 3000 OXYGEN MONITOR | Minesafety Appliances Co. | 1996-07-25 | 87 | 0 |
| K935370 | MINIOX IA OXYGEN ANALYZER | Minesafety Appliances Co. | 1994-08-02 | 271 | 0 |
| K935364 | MINIOX 1000 OXYGEN CONCENTRATION INDICATOR | Minesafety Appliances Co. | 1994-06-14 | 222 | 0 |
| K903200 | MINICAP III CO2 DETECTOR | Minesafety Appliances Co. | 1990-09-21 | 60 | 0 |
| K883090 | MINICAP TM 100 CAPNOMETER | Minesafety Appliances Co. | 1989-01-30 | 192 | 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