Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomedical Research & Development Laboratories, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884693 | UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS | Biomedical Research & Development Laboratories, Inc. | 1988-12-15 | 36 | 0 |
| K881655 | SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL | Biomedical Research & Development Laboratories, Inc. | 1988-05-27 | 42 | 0 |
| K834474 | H.P.T. HOME PREG. TEST KIT & A.P.T. | Biomedical Research & Development Laboratories, Inc. | 1984-09-28 | 283 | 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