Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Midmark Corporation — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
276 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-02 | Midmark Corporation | 2026-06-12 | 259 | 0 |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 2025-11-03 | 159 | 0 |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | 2024-04-04 | 195 | 0 |
| K201667 | Midmark Extraoral Imaging System (EOIS) | Midmark Corporation | 2020-08-06 | 48 | 0 |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Steriliz | Midmark Corporation | 2017-08-31 | 276 | 0 |
| K161909 | IQvitals Zone | Midmark Corporation | 2016-11-17 | 128 | 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