Medovations, Inc.: FDA clearances and approvals
Medovations, Inc. has 31 FDA 510(k) clearances (first 1983, latest 2015), across 20 product codes in 5 review panels. Median 510(k) review time: 59 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 223 |
| 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 10 | 10 |
| KNQ | Dilator, Esophageal | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BTK | Strap, Head, Gas Mask | 1 | 1 |
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| BZB | Catheter, Nasal, Oxygen | 1 | 1 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 | 1 |
Plus 10 more product codes.
Review panels
- Gastroenterology and Urology (17)
- Anesthesiology (6)
- General and Plastic Surgery (4)
- General Hospital (2)
- Neurology (1)
Most recent Medovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | OCX | 2015-03-10 | 223 |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | KNQ | 2000-11-01 | 90 |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | FAT | 1998-02-02 | 242 |
| K924646 | OVER THE GUIDEWIRE DILATATION SYSTEM | KNQ | 1994-12-05 | 812 |
| K913678 | TROCAR CATHETER | KGY | 1991-12-16 | 119 |
| K905478 | YANKAUER SUCTION DEVICE | MDM | 1990-12-19 | 13 |
| K874309 | URETHAL CATHETER | KNX | 1987-12-07 | 48 |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | KOA | 1987-10-14 | 296 |
| K864962 | OBERTO MOUTH PROP | JXL | 1987-02-19 | 59 |
| K864964 | 5 - IN - 1 CONNECTOR | GAZ | 1987-01-20 | 29 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medovations, Inc..
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 Medovations, Inc. have?
Medovations, Inc. has 31 FDA 510(k) clearances (first 1983, latest 2015), across 20 product codes in 5 review panels.
How long does FDA take to clear Medovations, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medovations, Inc.'s cleared 510(k)s is 59 days.
What devices does Medovations, Inc. make?
Its most frequent FDA product codes are KNT (Tubes, Gastrointestinal (And Accessories), 10); KNQ (Dilator, Esophageal, 3); BSJ (Mask, Gas, Anesthetic, 1).
Has Medovations, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medovations, Inc. Related entities may recall under other names.
Next steps
- See all 31 Medovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Medovations, Inc.'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.