Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beckman — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
98 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IM | Beckman | 1999-06-01 | 13 | 0 |
| K971534 | SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL | Beckman | 1997-05-21 | 23 | 0 |
| K935362 | P-AMYLASE CONTROL | Beckman | 1994-01-27 | 84 | 0 |
| K904219 | SYNCHRON CX 7 CLINICAL ANALYZER | Beckman | 1990-10-22 | 40 | 0 |
| K904220 | SYNCHRON CX4-CE | Beckman | 1990-10-15 | 33 | 1 |
| K893583 | BECKMAN CHOLINESTERASE REAGENT KIT | Beckman | 1989-08-15 | 98 | 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