Midmark Corp.: FDA clearances and approvals
Midmark Corp. has 39 FDA 510(k) clearances (first 1981, latest 2026), across 19 product codes in 7 review panels. Median 510(k) review time: 89 days. Since 2017 its median was 195 days, against 147 days for all cleared 510(k)s in the same product codes. openFDA lists 7 product recalls by a recalling firm named Midmark Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 211 |
| 2013 | 1 | 131 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 128 |
| 2017 | 1 | 276 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 48 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 195 |
| 2025 | 1 | 159 |
| 2026 | 1 | 259 |
Review time against the same product codes
Since 2017, Midmark Corp.'s cleared 510(k)s took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLE | Sterilizer, Steam | 9 | 9 |
| LGX | Table, Examination, Medical, Powered | 4 | 4 |
| EIA | Unit, Operative Dental | 3 | 3 |
| ETF | Unit, Examining/Treatment, Ent | 3 | 3 |
| MUH | System, X-Ray, Extraoral Source, Digital | 3 | 3 |
| FPO | Stretcher, Wheeled | 2 | 2 |
| FQO | Table, Operating-Room, Ac-Powered | 2 | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FMS | Bed, Pediatric Open Hospital | 1 | 1 |
Plus 9 more product codes.
Review panels
- General Hospital (18)
- Radiology (5)
- General and Plastic Surgery (5)
- Dental (3)
- Ear, Nose and Throat (3)
- Cardiovascular (2)
- Physical Medicine (2)
Most recent Midmark Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | MWI | 2026-06-12 | 259 |
| K251626 | Midmark Dental Delivery System | EIA | 2025-11-03 | 159 |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | FLE | 2024-04-04 | 195 |
| K201667 | Midmark Extraoral Imaging System (EOIS) | OAS | 2020-08-06 | 48 |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer | FLE | 2017-08-31 | 276 |
| K161909 | IQvitals Zone | MWI | 2016-11-17 | 128 |
| K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C | MUH | 2013-01-07 | 131 |
| K120239 | ELEVANCE | EIA | 2012-08-24 | 211 |
| K112380 | CLEARVISION | MUH | 2011-11-22 | 97 |
| K091866 | PROGENY VANTAGE PANORAMIC X-RAY SYSTEM | MUH | 2009-07-20 | 26 |
29 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 3 recall events; 6 initiated in the last five years. Most recent: 2026-08-21.
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 Midmark Corp. have?
Midmark Corp. has 39 FDA 510(k) clearances (first 1981, latest 2026), across 19 product codes in 7 review panels.
How long does FDA take to clear Midmark Corp.'s 510(k)s?
The median time from FDA receipt to decision across Midmark Corp.'s cleared 510(k)s is 89 days. Since 2017: 195 days, versus 147 days for all cleared 510(k)s in the same product codes.
What devices does Midmark Corp. make?
Its most frequent FDA product codes are FLE (Sterilizer, Steam, 9); LGX (Table, Examination, Medical, Powered, 4); EIA (Unit, Operative Dental, 3).
Has Midmark Corp. had device recalls?
openFDA lists 7 product recalls in 3 recall events by a recalling firm whose name matches Midmark Corp; the most recent began 2026-08-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 39 Midmark Corp. clearances with predicates and recalls
- Run predicate analysis for product code FLE, Midmark 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.