Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OED · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122365 | ULTRACHECK CURVE BLOOD PRESSURE CUFFS | Statcorp Medical | 2013-06-04 | 302 | 0 |
| K071885 | ANTIMICROBIAL AND SINGLE-PATIENT CUFFS | Philips Medical Systems | 2007-12-20 | 164 | 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