Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KQA · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914784 | PAPILLION PROCTOSCOPE | Oldelft Corp. of America | 1992-06-05 | 226 | 0 |
| K885126 | PHILIPS RT250 COLLIMATOR (PK8050) | Perkins Mfg. Co. | 1989-06-01 | 171 | 0 |
| K844180 | THE MCP-70-SE SYSTEM | Ellis Pharmaceutical Consulting, Inc. | 1985-02-01 | 98 | 0 |
| K790168 | COLLIMATOR, BILATERIAL | Cmsi | 1979-02-15 | 23 | 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