Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hyman, Phelps & McNamara, P.C. · 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) |
|---|---|---|---|---|---|
| K950530 | PRO-TEC-CASE | Hyman, Phelps & McNamara, P.C. | 1995-04-07 | 59 | 0 |
| K950878 | MENICON SP VIAL | Hyman, Phelps & McNamara, P.C. | 1995-04-07 | 38 | 0 |
| K945834 | PROPHY PRO. | Hyman, Phelps & McNamara, P.C. | 1995-02-13 | 76 | 0 |
| K915574 | COMFORT PERSONAL LUBRICANT | Hyman, Phelps & McNamara, P.C. | 1993-02-19 | 435 | 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