Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FFN · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
133 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932408 | AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS | Baxter Healthcare Corp | 1993-09-28 | 133 | 0 |
| K892542 | RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU | Zinnanti Surgical Instruments, Inc. | 1989-05-09 | 28 | 0 |
| K892550 | BEST COLON CLAMP | Zinnanti Surgical Instruments, Inc. | 1989-05-09 | 28 | 0 |
| K772405 | TUBING CLAMP | Fred Sammons, Inc. | 1978-01-26 | 30 | 0 |
| K771421 | CATHETEO CLAMP | Quinton, Inc. | 1977-10-25 | 85 | 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