Medical Device Consultants, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Medical Device Consultants, Inc.” (first 1982, latest 2002), across 11 product codes in 8 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 4 | 4 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| FFK | Lithotriptor, Electro-Hydraulic | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| INN | Chair, Adjustable, Mechanical | 1 | 1 |
| JBP | Activated Whole Blood Clotting Time | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (5)
- Gastroenterology and Urology (2)
- Hematology (2)
- Clinical Chemistry (1)
- Cardiovascular (1)
- General Hospital (1)
- Physical Medicine (1)
- Radiology (1)
Most recent Medical Device Consultants, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022895 | ELCAM STOPCOCKS AND MANIFOLDS | FMG | 2002-10-18 | 45 |
| K002699 | PARIETEX COMPOSITE (PCO) MESH | FTL | 2001-02-15 | 169 |
| K002116 | S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 | DTQ | 2000-08-09 | 27 |
| K000551 | IMAGE X-70 PLUS DENTAL X-RAY UNIT | EHD | 2000-03-16 | 27 |
| K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | FFK | 1997-12-18 | 43 |
| K864282 | GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA | CGA | 1987-05-26 | 208 |
| K860122 | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME | JBP | 1986-04-04 | 80 |
| K860932 | ULTRASUN 1000 & 2000 SUNTANNING UNIT | FTC | 1986-03-28 | 17 |
| K860931 | ULTRASUN 3000 AND 5000 SUNTANNING UNIT | FTC | 1986-03-28 | 17 |
| K860930 | ULTRASUN 2500 SUNTANNING UNIT | FTC | 1986-03-28 | 17 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Device Consultants, 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 Devices, Inc. (49 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Device Consultants, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Medical Device Consultants, Inc.” (first 1982, latest 2002), across 11 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 Device Consultants, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Device Consultants, Inc. is 35 days.
Which FDA product codes appear under Medical Device Consultants, Inc.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 4); CGA (Glucose Oxidase, Glucose, 1); DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass, 1).
Next steps
- See all 14 Medical Device Consultants, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Medical Device Consultants, 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.