Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biometrix , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151040 | Art-line Single channel blood pressure system, Art-line Doub | Biometrix , Ltd. | 2015-09-04 | 137 | 0 |
| K011216 | PVC FREE INTRAVASCULAR ADMINISTRATION SET | Biometrix , Ltd. | 2001-07-18 | 89 | 0 |
| K001461 | TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET | Biometrix , Ltd. | 2000-09-11 | 124 | 0 |
| K925040 | TELEPULSE | Biometrix , Ltd. | 1993-08-23 | 322 | 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