Biomedical Dynamics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biomedical Dynamics, Inc.” (first 1985, latest 1992), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | 3 | 3 |
| DXQ | Blood Pressure Cuff | 2 | 2 |
| FCY | Bulb, Inflation, For Endoscope | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Review panels
Most recent Biomedical Dynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915074 | IRRIGATOR/ASPIRATOR PROBE | HMX | 1992-02-05 | 89 |
| K913751 | PRESSURE INFUSER | KZD | 1992-01-09 | 141 |
| K911213 | CUFFABLE | DXQ | 1991-08-07 | 141 |
| K911216 | INFUSABLE | KZD | 1991-07-22 | 125 |
| K911324 | IRRIGATION/ASPIRATION TUBING SET | KDH | 1991-06-24 | 90 |
| K904376 | ANEROID BLOOD PRESSURE GAUGE | FCY | 1990-12-20 | 86 |
| K890268 | PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION | KPE | 1989-05-05 | 107 |
| K881799 | BLOOD PRESSURE CUFF | DXQ | 1988-10-14 | 170 |
| K861977 | BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR | KZD | 1986-07-15 | 55 |
| K850506 | CORRECT FLO INTRAVASCULAR ADMINISTRATION SET | FPA | 1985-04-01 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Biomedical Dynamics, 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.
- Biomedical Life Systems, Inc. (37 510(k)s)
- Biomedical Ent., Inc. (13 510(k)s)
- Biomedical Diagnostics (Bmd) SA (10 510(k)s)
- Biomedical Enterprises, Inc. (10 510(k)s)
- Biomedical Devices, Inc. (7 510(k)s)
- Biomedical Concepts, Inc. (3 510(k)s)
- Biomedical Design Instruments (3 510(k)s)
- Biomedical Research & Development Laboratories, Inc. (3 510(k)s)
- Biomedical Sensors, Inc. (3 510(k)s)
- Biomedical Systems Corp. (3 510(k)s)
- Biomedical Composites, Ltd. (2 510(k)s)
- Biomedical Exports, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomedical Dynamics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Biomedical Dynamics, Inc.” (first 1985, latest 1992), across 7 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 Biomedical Dynamics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedical Dynamics, Inc. is 98 days.
Which FDA product codes appear under Biomedical Dynamics, Inc.?
The most frequent FDA product codes under this applicant name are KZD (Infusor, Pressure, For I.V. Bags, 3); DXQ (Blood Pressure Cuff, 2); FCY (Bulb, Inflation, For Endoscope, 1).
Next steps
- See all 10 Biomedical Dynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KZD, Biomedical Dynamics, 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.