Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biodynamics Corp. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
148 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051675 | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER | Biodynamics Corp. | 2006-03-16 | 266 | 0 |
| K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER | Biodynamics Corp. | 1988-11-17 | 55 | 0 |
| K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR | Biodynamics Corp. | 1988-09-09 | 148 | 0 |
| K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER | Biodynamics Corp. | 1988-07-28 | 78 | 0 |
| K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER | Biodynamics Corp. | 1988-03-16 | 145 | 0 |
| K873807 | AUTOTRANSFUSION APPARATUS | Biodynamics Corp. | 1988-03-09 | 173 | 0 |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | Biodynamics Corp. | 1987-10-23 | 18 | 0 |
| K870052 | INFUMIX MIXING CONTAINER | Biodynamics Corp. | 1987-02-27 | 51 | 0 |
| K822716 | UNIVERSAL CENTRIFUGE | Biodynamics Corp. | 1982-09-30 | 23 | 0 |
| K822715 | PLATELET CENTRIFUGE | Biodynamics Corp. | 1982-09-30 | 23 | 0 |
| K822422 | BASIC CENTRIFUGE | Biodynamics Corp. | 1982-09-02 | 21 | 0 |
| K821741 | URICACID | Biodynamics Corp. | 1982-07-02 | 18 | 0 |
| K821091 | ACCUCHEK BG. | Biodynamics Corp. | 1982-05-14 | 25 | 0 |
| K820465 | CHEMSTRIP UG | Biodynamics Corp. | 1982-03-11 | 17 | 0 |
| K812677 | UNITEST-POTASSIUM | Biodynamics Corp. | 1981-10-02 | 10 | 0 |
| K811189 | CHEMSTRIP L | Biodynamics Corp. | 1981-07-27 | 89 | 0 |
| K811680 | ACCUDEX | Biodynamics Corp. | 1981-07-23 | 38 | 0 |
| K810075 | AUTOCLIX | Biodynamics Corp. | 1981-02-04 | 22 | 0 |
| K810105 | BCA 1000 | Biodynamics Corp. | 1981-02-02 | 17 | 0 |
| K802842 | SINGLE VIAL LIPASE TEST KIT | Biodynamics Corp. | 1980-12-18 | 36 | 0 |
| K802521 | CK-MB(IMMUNOLOGICAL) | Biodynamics Corp. | 1980-11-12 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda