Reverse Medical Corporation: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Reverse Medical Corporation” (first 2009, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 98 |
| 2013 | 3 | 197 |
| 2014 | 1 | 29 |
| 2015 | 1 | 92 |
| 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 5 | 5 |
| KRD | Device, Vascular, For Promoting Embolization | 4 | 4 |
| MMX | Device, Percutaneous Retrieval | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent Reverse Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150108 | Reverse Medical Micro Vascular Plug System | KRD | 2015-04-22 | 92 |
| K141313 | REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM | KRD | 2014-06-18 | 29 |
| K133282 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | KRD | 2013-11-27 | 33 |
| K130858 | REVERSE MEDICAL MICROCATHETER | DQY | 2013-10-11 | 197 |
| K123803 | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM | KRD | 2013-07-02 | 204 |
| K122684 | REVERSE MEDICAL MICROCATHETER | DQY | 2012-12-07 | 98 |
| K112262 | REFLEX BALLON GUIDE CATHETER | DQY | 2011-11-02 | 86 |
| K102418 | REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM | DQY | 2011-04-15 | 233 |
| K110055 | REVERSE MEDICAL REFLEX GUIDE CATHETER | DQY | 2011-04-05 | 85 |
| K091563 | RECRUIT MICROCATHETER | MMX | 2009-07-30 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Reverse Medical Corporation.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Reverse Medical Corporation?
FDA lists 10 510(k) clearances under the applicant name “Reverse Medical Corporation” (first 2009, latest 2015), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Reverse Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reverse Medical Corporation is 89 days.
Which FDA product codes appear under Reverse Medical Corporation?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 5); KRD (Device, Vascular, For Promoting Embolization, 4); MMX (Device, Percutaneous Retrieval, 1).
Next steps
- See all 10 Reverse Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code DQY, Reverse Medical Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.