Medical Parameters, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medical Parameters, Inc.” (first 1983, latest 1986), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| BZW | Stethoscope, Esophageal | 1 | 1 |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- Cardiovascular (2)
- General Hospital (2)
- Anesthesiology (1)
- Clinical Toxicology (1)
Most recent Medical Parameters, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862190 | WALRUS: DOUBLE BALLOON SHUNTING CATHETER | DWF | 1986-11-03 | 147 |
| K844444 | ESOPHAGEAL STETHOSCOPE | BZW | 1985-01-10 | 55 |
| K833825 | MULTI-LUMEN INTRAVENOUS INFUSION CATH | DQY | 1984-01-10 | 69 |
| K830754 | BLOOD PRESSURE MONITORING KITS,WALRUS | DXT | 1983-08-12 | 155 |
| K831239 | WALRUS PERCUTANEOUS INTRODUCER SET | DOY | 1983-05-25 | 40 |
| K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- | FPA | 1983-04-28 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Parameters, 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 Parameters, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Medical Parameters, Inc.” (first 1983, latest 1986), across 6 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 Parameters, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Parameters, Inc. is 62 days.
Which FDA product codes appear under Medical Parameters, Inc.?
The most frequent FDA product codes under this applicant name are BZW (Stethoscope, Esophageal, 1); DOY (Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep., 1); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 6 Medical Parameters, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZW, Medical Parameters, 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.