Medical Specialties, Inc.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Medical Specialties, Inc.” (first 1979, latest 1995), across 34 product codes in 7 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | 5 | 5 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 3 | 3 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGE | Orthotoluidine, Glucose | 1 | 1 |
Plus 24 more product codes.
Review panels
- Clinical Chemistry (24)
- Hematology (11)
- Cardiovascular (1)
- General Hospital (1)
- Microbiology (1)
- Pathology (1)
- Physical Medicine (1)
Most recent Medical Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946201 | STAND, INFUSION | FOX | 1995-04-18 | 118 |
| K931947 | CHECKPOINT | JPK | 1993-06-18 | 60 |
| K926095 | REFRACTROL-SP | JJX | 1993-01-26 | 55 |
| K924926 | MSI-HCT | GLK | 1993-01-07 | 99 |
| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | JWY | 1990-02-09 | 81 |
| K883851 | MSI-CAL 8 | KRZ | 1988-11-22 | 84 |
| K883850 | MSI-CAL 16 | KRZ | 1988-11-22 | 84 |
| K883703 | MSI-CAL 7 | KRZ | 1988-11-22 | 84 |
| K880608 | MSI-PC | GJP | 1988-03-21 | 38 |
| K880270 | MSI-DIFF PLUS | JPK | 1988-03-01 | 40 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Specialties, 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 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 Specialties, Inc.?
FDA lists 40 510(k) clearances under the applicant name “Medical Specialties, Inc.” (first 1979, latest 1995), across 34 product codes in 7 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 Specialties, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Specialties, Inc. is 50 days.
Which FDA product codes appear under Medical Specialties, Inc.?
The most frequent FDA product codes under this applicant name are JPK (Mixture, Hematology Quality Control, 5); KRZ (Calibrator For Hemoglobin And Hematocrit Measurement, 3); CDH (Acid, Uric, Phosphotungstate Reduction, 1).
Next steps
- See all 40 Medical Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPK, Medical Specialties, 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.