Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FKK · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
79 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854512 | TUBING CLAMP CAT#1000-A | Rao Medical Devices, Inc. | 1985-12-02 | 20 | 0 |
| K854517 | NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET | Travenol Laboratories, S.A. | 1985-12-02 | 20 | 0 |
| K844121 | CLAMP, TUBING, LINE | Dyn-A-Med Products | 1984-12-17 | 55 | 0 |
| K831689 | EMPTY DIALYSATE CONTAINER | Delmed, Inc. | 1983-08-11 | 79 | 0 |
| K822551 | AMP CAPD UNISPIKE AMINISTRATION SET | American Medical Products, Inc. | 1982-10-13 | 50 | 0 |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Pollak (Intl.), Ltd. | 1980-10-31 | 72 | 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