Medical Equipment Designs, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Medical Equipment Designs, Inc.” (first 1982, latest 1991), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 5 | 5 |
| HLH | Pupillometer, Manual | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| HCS | Device, Temperature Measurement, Direct Contact, Powered | 1 | 1 |
| HLR | Keratoscope, Battery-Powered | 1 | 1 |
| HOJ | Screen, Tangent, Target | 1 | 1 |
| HPA | Frame, Trial, Ophthalmic | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
- Anesthesiology (5)
- Ophthalmic (5)
- Cardiovascular (1)
- Neurology (1)
- Physical Medicine (1)
Most recent Medical Equipment Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911308 | CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE | DXH | 1991-09-11 | 173 |
| K894152 | MEDITHERM | IMI | 1990-06-11 | 362 |
| K895375 | MULTISPIRO | BZG | 1989-11-27 | 89 |
| K851277 | MICROSPIRO-SDS | BZG | 1985-04-19 | 18 |
| K840929 | FRC 85 SERIES SPIROMETER | BZG | 1984-05-14 | 73 |
| K840908 | CHESTAC-25F SPIROMETER | BZG | 1984-05-14 | 75 |
| K821107 | EXOPHTHALMOMETER | HCS | 1982-06-14 | 55 |
| K821084 | UNIVERSAL TRIAL FRAMEE | HPA | 1982-06-14 | 56 |
| K821083 | P.D. METER | HLH | 1982-06-14 | 56 |
| K821082 | TRIAL LENS SET | HLH | 1982-06-14 | 56 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Equipment Designs, 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 Equipment Designs, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Medical Equipment Designs, Inc.” (first 1982, latest 1991), across 8 product codes in 5 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 Equipment Designs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Equipment Designs, Inc. is 56 days.
Which FDA product codes appear under Medical Equipment Designs, Inc.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 5); HLH (Pupillometer, Manual, 2); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Next steps
- See all 13 Medical Equipment Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Medical Equipment Designs, 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.