Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FII · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
117 daysmedian FDA review time
153 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030470 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2003-07-07 | 145 | 0 |
| K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | Gambro, Inc. | 1988-08-24 | 153 | 0 |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Travenol Laboratories, S.A. | 1987-10-13 | 117 | 2 |
| K862716 | HEMOFILTRATION SYSTEM 10 | Gambro, Inc. | 1986-09-09 | 54 | 0 |
| K822386 | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA | Hospal Medical Corp. | 1982-10-06 | 58 | 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