Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cerner Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
118 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121758 | CERNER FETALINK+(VERSION1.0) | Cerner Corp. | 2012-10-09 | 116 | 0 |
| K093134 | CERNER CAREAWARE IBUS | Cerner Corp. | 2009-11-27 | 53 | 0 |
| K091251 | CERNER FETALINK (VERSION 1.0) | Cerner Corp. | 2009-08-25 | 118 | 0 |
| K091032 | CERNER PROVISION WORKSTATION (VERSION 2.5) | Cerner Corp. | 2009-06-22 | 73 | 0 |
| K070394 | CERNER PROVISION WORKSTATION | Cerner Corp. | 2007-03-27 | 46 | 0 |
| K000770 | PROVIEW MEDICAL IMAGE DISPLAY MODULE | Cerner Corp. | 2000-05-16 | 68 | 0 |
| K955000 | REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE | Cerner Corp. | 1996-01-26 | 86 | 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