Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kirk Specialty Systems — 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) |
|---|---|---|---|---|---|
| K962098 | ESOPHAGEAL INTUBATION DETECTOR | Kirk Specialty Systems | 1996-10-08 | 132 | 0 |
| K952512 | CAPNO-FLO REGULATOR, CAPNO-FLO | Kirk Specialty Systems | 1995-08-28 | 90 | 0 |
| K945822 | CAPNO-FLO(TM) REGULATOR | Kirk Specialty Systems | 1995-02-24 | 87 | 0 |
| K933626 | CAPNO-FLO | Kirk Specialty Systems | 1993-10-06 | 82 | 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