Biodynamics Corp.: FDA clearances and approvals
Biodynamics Corp. has 21 FDA 510(k) clearances (first 1980, latest 2006), across 15 product codes in 6 review panels. Median 510(k) review time: 28 days.
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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 2 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 2 | 2 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 | 1 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
| GHD | Test, Leukocyte Alkaline Phosphatase | 1 | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (10)
- Cardiovascular (5)
- Gastroenterology and Urology (2)
- Hematology (2)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Biodynamics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051675 | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER | MNW | 2006-03-16 | 266 |
| K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER | DSB | 1988-11-17 | 55 |
| K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR | CAC | 1988-09-09 | 148 |
| K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER | DSB | 1988-07-28 | 78 |
| K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER | DSB | 1988-03-16 | 145 |
| K873807 | AUTOTRANSFUSION APPARATUS | CAC | 1988-03-09 | 173 |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | LIF | 1987-10-23 | 18 |
| K870052 | INFUMIX MIXING CONTAINER | KPE | 1987-02-27 | 51 |
| K822716 | UNIVERSAL CENTRIFUGE | JPI | 1982-09-30 | 23 |
| K822715 | PLATELET CENTRIFUGE | JQC | 1982-09-30 | 23 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biodynamics Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biodynamics Corp. have?
Biodynamics Corp. has 21 FDA 510(k) clearances (first 1980, latest 2006), across 15 product codes in 6 review panels.
How long does FDA take to clear Biodynamics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Biodynamics Corp.'s cleared 510(k)s is 28 days.
What devices does Biodynamics Corp. make?
Its most frequent FDA product codes are DSB (Plethysmograph, Impedance, 3); CAC (Apparatus, Autotransfusion, 2); CGA (Glucose Oxidase, Glucose, 2).
Has Biodynamics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biodynamics Corp. Related entities may recall under other names.
Next steps
- See all 21 Biodynamics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DSB, Biodynamics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.