Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Princeton Regulatory Assoc. — 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) |
|---|---|---|---|---|---|
| K965136 | UROSURGE UROTHERM FLUID WARMING SYSTEM | Princeton Regulatory Assoc. | 1998-10-16 | 662 | 0 |
| K972158 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | Princeton Regulatory Assoc. | 1998-02-20 | 256 | 0 |
| K973504 | UROSURGE UROSTENT | Princeton Regulatory Assoc. | 1998-01-30 | 136 | 0 |
| K962770 | UROSURGE ACUTRAINER | Princeton Regulatory Assoc. | 1996-08-01 | 16 | 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