Medical Specialties Intl., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medical Specialties Intl., Inc.” (first 1989, latest 1997), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| GJR | Control, Red-Cell | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| JCN | Control, Cell Counter, Normal And Abnormal | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
Review panels
- Hematology (2)
- Clinical Chemistry (1)
- Cardiovascular (1)
- Radiology (1)
Most recent Medical Specialties Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972655 | CONTROL SYRINGE | IZI | 1997-11-04 | 112 |
| K972654 | MANIFOLD | DTL | 1997-10-08 | 85 |
| K952385 | HEMA-TROL Q-CHECK | JJY | 1995-09-25 | 126 |
| K940430 | SEDRATROL | GJR | 1995-02-06 | 371 |
| K895373 | HEMATOLOGY CONTROL | JCN | 1989-10-06 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Specialties Intl., 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 Specialties Intl., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Medical Specialties Intl., Inc.” (first 1989, latest 1997), across 5 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 Specialties Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Specialties Intl., Inc. is 112 days.
Which FDA product codes appear under Medical Specialties Intl., Inc.?
The most frequent FDA product codes under this applicant name are DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 1); GJR (Control, Red-Cell, 1); IZI (System, X-Ray, Angiographic, 1).
Next steps
- See all 5 Medical Specialties Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTL, Medical Specialties Intl., 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.