Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomedical Dynamics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
170 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915074 | IRRIGATOR/ASPIRATOR PROBE | Biomedical Dynamics, Inc. | 1992-02-05 | 89 | 0 |
| K913751 | PRESSURE INFUSER | Biomedical Dynamics, Inc. | 1992-01-09 | 141 | 0 |
| K911213 | CUFFABLE | Biomedical Dynamics, Inc. | 1991-08-07 | 141 | 1 |
| K911216 | INFUSABLE | Biomedical Dynamics, Inc. | 1991-07-22 | 125 | 0 |
| K911324 | IRRIGATION/ASPIRATION TUBING SET | Biomedical Dynamics, Inc. | 1991-06-24 | 90 | 0 |
| K904376 | ANEROID BLOOD PRESSURE GAUGE | Biomedical Dynamics, Inc. | 1990-12-20 | 86 | 0 |
| K890268 | PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION | Biomedical Dynamics, Inc. | 1989-05-05 | 107 | 0 |
| K881799 | BLOOD PRESSURE CUFF | Biomedical Dynamics, Inc. | 1988-10-14 | 170 | 0 |
| K861977 | BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR | Biomedical Dynamics, Inc. | 1986-07-15 | 55 | 0 |
| K850506 | CORRECT FLO INTRAVASCULAR ADMINISTRATION SET | Biomedical Dynamics, Inc. | 1985-04-01 | 52 | 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