Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LFP · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
74 daysmedian FDA review time
386 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990039 | GAMBRO DQM 200 | Gambro Healthcare | 2000-01-27 | 386 | 0 |
| K992847 | HICHEM BUN REAGENT | Elan Holdings, Inc. | 1999-10-14 | 51 | 0 |
| K963537 | SIGMA DIAGNOSTICS BUN REAGENT | Sigma Diagnostics, Inc. | 1996-10-24 | 50 | 0 |
| K933679 | SIGMA BUN REAGENT | Sigma Chemical Co. | 1993-12-17 | 142 | 0 |
| K873132 | BUN REAGENT KIT | A-Kem, Inc. | 1987-10-23 | 74 | 0 |
| K812945 | LIQUILYME BUN REAGENT | Amresco, Inc. | 1981-11-06 | 17 | 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