Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DGR · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
155 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961544 | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | Consolidated Technologies, Inc. | 1996-09-24 | 155 | 0 |
| K902220 | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL | Boehringer Mannheim Corp. | 1990-09-05 | 111 | 0 |
| K865014 | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II | Bio-Rad | 1987-01-09 | 17 | 0 |
| K790298 | RADIOASSAY, CONTROL SERUM I, II, III | Kallestad Laboratories, Inc. | 1979-04-04 | 51 | 0 |
| K781355 | ICS NORMAL CONTROL SERUM | Beckman Instruments, Inc. | 1978-08-31 | 24 | 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