Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FJH · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | National Medical Care, Medical Products Div., Inc. | 1992-09-21 | 220 | 0 |
| K861646 | BIO-CARB D16000, D16001, AND D17000 | Societe D' Analyses Bio-Pharmaceutiques,Inc. | 1986-08-07 | 99 | 0 |
| K852764 | IDECAP DIALYZER | Trans-National Trade Development Corp. | 1985-09-20 | 84 | 0 |
| K822395 | CF 1211 CAPILLARY FLOW DIALYZER CODE | Travenol Laboratories, S.A. | 1982-08-12 | 1 | 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