Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FFO · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
130 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993544 | SPACE-OR RETRACTOR | Advanced Surgical Concepts (Asc) | 1999-12-22 | 64 | 0 |
| K870897 | KODNER ANAL PERIONEAL RETRACTOR | Sur-Med Instruments, Inc. | 1987-06-04 | 91 | 0 |
| K860368 | URDYN 5000 (UROFLOWMETER) | Dantec Electronics, Inc. | 1986-04-23 | 79 | 0 |
| K853119 | URODYN 1000 | Dantec Electronics, Inc. | 1985-10-04 | 71 | 0 |
| K852083 | THE KENDALL URINARY OUTPUT MONITOR | The Kendal Co. | 1985-09-20 | 130 | 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