Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FJB · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883490 | ACCUFLO UF CONTROL MODULE NO. 74-0100-3 | National Medical Care, Medical Products Div., Inc. | 1988-09-29 | 44 | 0 |
| K881062 | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 | Cobe Laboratories, Inc. | 1988-04-21 | 38 | 0 |
| K875312 | UFR DIGITAL RETROFIT | Yankee Intl. Medical Research & Mfg., Ltd. | 1988-02-19 | 52 | 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