Cerner Corp.: FDA clearances and approvals
Cerner Corp. has 8 FDA 510(k) clearances (first 1996, latest 2015), across 5 product codes in 3 review panels. Median 510(k) review time: 80 days. openFDA lists 2 product recalls by a recalling firm named Cerner Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 116 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 182 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Radiology (4)
- Cardiovascular (2)
- Obstetrics and Gynecology (2)
Most recent Cerner Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151672 | Cerner CareAware Event Management | MSX | 2015-12-21 | 182 |
| K121758 | CERNER FETALINK+(VERSION1.0) | HGM | 2012-10-09 | 116 |
| K093134 | CERNER CAREAWARE IBUS | DRG | 2009-11-27 | 53 |
| K091251 | CERNER FETALINK (VERSION 1.0) | HGM | 2009-08-25 | 118 |
| K091032 | CERNER PROVISION WORKSTATION (VERSION 2.5) | LLZ | 2009-06-22 | 73 |
| K070394 | CERNER PROVISION WORKSTATION | LLZ | 2007-03-27 | 46 |
| K000770 | PROVIEW MEDICAL IMAGE DISPLAY MODULE | LLZ | 2000-05-16 | 68 |
| K955000 | REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE | LMD | 1996-01-26 | 86 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2009-01-19.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cerner Corp. have?
Cerner Corp. has 8 FDA 510(k) clearances (first 1996, latest 2015), across 5 product codes in 3 review panels.
How long does FDA take to clear Cerner Corp.'s 510(k)s?
The median time from FDA receipt to decision across Cerner Corp.'s cleared 510(k)s is 80 days.
What devices does Cerner Corp. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 3); HGM (System, Monitoring, Perinatal, 2); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1).
Has Cerner Corp. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Cerner Corp; the most recent began 2009-01-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Cerner Corp. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Cerner Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.