Medical Device Technologies, Inc.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Medical Device Technologies, Inc.” (first 1992, latest 2010), across 20 product codes in 6 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | 15 | 15 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 | 4 |
| DRC | Trocar | 3 | 3 |
| GAA | Needle, Aspiration And Injection, Disposable | 3 | 3 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| FDX | Endoscopic Cytology Brush | 2 | 2 |
| KNY | Accessories, Catheter, G-U | 2 | 2 |
| LJE | Catheter, Nephrostomy | 2 | 2 |
| NEU | Marker, Radiographic, Implantable | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
Plus 10 more product codes.
Review panels
- General and Plastic Surgery (21)
- Gastroenterology and Urology (12)
- Cardiovascular (8)
- General Hospital (2)
- Obstetrics and Gynecology (2)
- Radiology (1)
Most recent Medical Device Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101832 | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT | KNW | 2010-08-27 | 57 |
| K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | NEU | 2006-01-26 | 38 |
| K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | NEU | 2005-08-30 | 90 |
| K050873 | CANALIZER HYDROPHILIC GUIDE WIRE | DQX | 2005-05-26 | 50 |
| K043523 | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE | KNW | 2005-02-11 | 53 |
| K042464 | V-CORE FULL CORE BREAST BIOPSY INSTRUMENT | KNW | 2004-09-30 | 17 |
| K040427 | FIBREX CATHETER PATENCY DEVICE | FOZ | 2004-05-03 | 74 |
| K031442 | PBN GUIDEWIRES | DQX | 2003-08-13 | 99 |
| K021606 | EN-SNARE ENDOVASCULAR SNARE AND CATHETER | MMX | 2002-05-31 | 15 |
| K011790 | MICROCRUISER PLUS INTRODUCER SET | DYB | 2001-09-05 | 89 |
36 earlier clearances. See the full list in Caduvo.
Recalls
50 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2010-12-22.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medical Device Technologies, Inc. (a text match, not an official crosswalk):
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 Devices, Inc. (49 510(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 Device Technologies, Inc.?
FDA lists 46 510(k) clearances under the applicant name “Medical Device Technologies, Inc.” (first 1992, latest 2010), across 20 product codes in 6 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 Device Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Device Technologies, Inc. is 46 days.
Which FDA product codes appear under Medical Device Technologies, Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 15); FGE (Stents, Drains And Dilators For The Biliary Ducts, 4); DRC (Trocar, 3).
Next steps
- See all 46 Medical Device Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Medical Device Technologies, 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.