Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cygnus Research Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
64 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831556 | VAPOR-PHASE HUMIDIFIER SYSTEM | Cygnus Research Corp. | 1983-07-19 | 64 | 0 |
| K831163 | LO-COMP RESERVOIR-RE-1000 | Cygnus Research Corp. | 1983-05-03 | 22 | 0 |
| K830923 | TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA | Cygnus Research Corp. | 1983-05-03 | 42 | 0 |
| K830922 | TEMP-CHECK ADAPTOR, TEE-CONFIGURATION | Cygnus Research Corp. | 1983-05-02 | 41 | 0 |
| K830921 | TEMP-CHECK ADAPTOR, Y-CONFIGURATION | Cygnus Research Corp. | 1983-05-02 | 41 | 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