Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zebra Medical Vision, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
259 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211803 | HealthPPT | Zebra Medical Vision, Ltd. | 2021-12-15 | 187 | 0 |
| K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021-09-15 | 245 | 0 |
| K202487 | HealthJOINT | Zebra Medical Vision, Ltd. | 2020-12-04 | 95 | 0 |
| K200905 | HealthMammo | Zebra Medical Vision, Ltd. | 2020-07-16 | 101 | 0 |
| K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020-05-12 | 210 | 0 |
| K192320 | HealthCXR | Zebra Medical Vision, Ltd. | 2019-11-26 | 92 | 0 |
| K190424 | HealthICH | Zebra Medical Vision, Ltd. | 2019-06-13 | 111 | 0 |
| K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019-05-06 | 80 | 0 |
| K172983 | HealthCCS | Zebra Medical Vision, Ltd. | 2018-06-13 | 259 | 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