Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bayer Medical Care, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
248 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2026-06-12 | 203 | 0 |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System | Bayer Medical Care, Inc. | 2026-02-13 | 155 | 0 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 | 163 | 0 |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2020-07-30 | 177 | 0 |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Works | Bayer Medical Care, Inc. | 2019-12-13 | 105 | 0 |
| K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | 2019-12-05 | 36 | 0 |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Works | Bayer Medical Care, Inc. | 2018-11-01 | 71 | 0 |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System | Bayer Medical Care, Inc. | 2018-11-01 | 71 | 0 |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Works | Bayer Medical Care, Inc. | 2018-08-17 | 248 | 0 |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System | Bayer Medical Care, Inc. | 2015-08-14 | 242 | 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