Medical Instruments Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medical Instruments Technology, Inc.” (first 1989, latest 2002), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| HRX | Arthroscope | 2 | 2 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| KCY | Tourniquet, Pneumatic | 1 | 1 |
| KQX | Goniometer, Ac-Powered | 1 | 1 |
Review panels
- Orthopedic (2)
- Cardiovascular (1)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Medical Instruments Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012614 | KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN | JOW | 2002-05-01 | 261 |
| K012640 | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS | HRX | 2002-02-28 | 199 |
| K012624 | REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS | HRX | 2001-11-08 | 87 |
| K012632 | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | KCY | 2001-10-26 | 74 |
| K884611 | THE ORTHORANGER II ELECTRONIC GONIOMETER | KQX | 1989-01-31 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Instruments Technology, 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 Instruments Technology, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Medical Instruments Technology, Inc.” (first 1989, latest 2002), across 4 product codes in 4 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 Instruments Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Instruments Technology, Inc. is 88 days.
Which FDA product codes appear under Medical Instruments Technology, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 2); JOW (Sleeve, Limb, Compressible, 1); KCY (Tourniquet, Pneumatic, 1).
Next steps
- See all 5 Medical Instruments Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Medical Instruments Technology, 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.