Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Medical Devices, Inc.” (first 1977, latest 2001), across 18 product codes in 8 review panels. Median 510(k) review time under this name: 80 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 16 | 16 |
| GXY | Electrode, Cutaneous | 7 | 7 |
| IPF | Stimulator, Muscle, Powered | 4 | 4 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| CAW | Generator, Oxygen, Portable | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| BSR | Stylet, Tracheal Tube | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| EYN | Tray, Irrigation, Sterile | 1 | 1 |
Plus 8 more product codes.
Review panels
- Neurology (24)
- Gastroenterology and Urology (9)
- General and Plastic Surgery (5)
- Physical Medicine (4)
- Anesthesiology (3)
- Cardiovascular (2)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | MKJ | 2001-02-05 | 194 |
| K930084 | MICRO-ARTHROSCOPE | HRX | 1995-09-01 | 967 |
| K943126 | ELECTROFLEX | GXY | 1994-12-05 | 159 |
| K940012 | SMARTBRACE ELECTRODE | GXY | 1994-12-05 | 335 |
| K935132 | HOME MICROCURRENT HMC | GZJ | 1994-03-14 | 137 |
| K934619 | FLEXMATE | GZJ | 1994-02-23 | 149 |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | GCT | 1993-07-06 | 280 |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | FWF | 1993-05-17 | 131 |
| K923914 | IF-II (TM), MODEL 7200 | IPF | 1992-11-06 | 98 |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | GEI | 1992-07-21 | 196 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Devices, Inc..
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
- Medical Instrument Development Laboratories, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Devices, Inc.?
FDA lists 49 510(k) clearances under the applicant name “Medical Devices, Inc.” (first 1977, latest 2001), across 18 product codes in 8 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 Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Devices, Inc. is 80 days.
Which FDA product codes appear under Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 16); GXY (Electrode, Cutaneous, 7); IPF (Stimulator, Muscle, Powered, 4).
Next steps
- See all 49 Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Medical Devices, 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.