Medivators, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Medivators, Inc.” (first 1987, latest 2023), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 142 days. Since 2017 the median was 98 days, against 108 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under STERIS, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 188 |
| 2015 | 1 | 104 |
| 2016 | 3 | 142 |
| 2017 | 1 | 105 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 36 |
| 2023 | 2 | 122 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medivators, Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | 4 | 4 |
| OCX | Endoscopic Irrigation/Suction System | 2 | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
| KTI | Bronchoscope Accessory | 1 | 1 |
| MED | Sterilant, Medical Devices | 1 | 1 |
| NIH | Disinfectant, Subsystem, Water Purification | 1 | 1 |
| NVE | Washer, Cleaner, Automated, Endoscope | 1 | 1 |
Review panels
Most recent Medivators, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231418 | ENDOGATOR Hybrid Irrigation Tubing | OCX | 2023-08-14 | 90 |
| K223040 | Endo SmartCap | FAJ | 2023-03-01 | 153 |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | FEB | 2022-01-14 | 36 |
| K172677 | Advantage Plus Pass-Thru | FEB | 2017-12-19 | 105 |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | FEB | 2016-12-21 | 142 |
| K160846 | AmplifEYE | FED | 2016-07-14 | 108 |
| K152394 | Rapicide PA High-Level Disinfectant Test Strips | JOJ | 2016-03-11 | 200 |
| K151522 | DEFENDO Bronchoscopy Suction Valve | KTI | 2015-09-17 | 104 |
| K133724 | MINNCARE HD | NIH | 2014-08-27 | 264 |
| K140753 | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM | OCX | 2014-07-15 | 111 |
3 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2021-04-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medivators (A Subsidiary of Steris Corporation) (3 510(k)s)
- Medivators Reprocessing Systems (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medivators, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Medivators, Inc.” (first 1987, latest 2023), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medivators, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medivators, Inc. is 142 days. Since 2017: 98 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medivators, Inc.?
The most frequent FDA product codes under this applicant name are FEB (Accessories, Cleaning, For Endoscope, 4); OCX (Endoscopic Irrigation/Suction System, 2); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 13 Medivators, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FEB, Medivators, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.