Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spegas Industries, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
250 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964239 | COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER | Spegas Industries, Ltd. | 1997-05-09 | 198 | 0 |
| K950387 | GEMINI | Spegas Industries, Ltd. | 1995-05-03 | 91 | 0 |
| K950388 | POLARIS | Spegas Industries, Ltd. | 1995-05-02 | 90 | 0 |
| K942849 | CAPNOSAT | Spegas Industries, Ltd. | 1995-02-21 | 250 | 0 |
| K933707 | CAPNODIG | Spegas Industries, Ltd. | 1993-10-27 | 89 | 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