Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomedix, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
194 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142097 | SELEC-3 I.V.ADMINISTRATION SET | Biomedix, Inc. | 2014-08-29 | 28 | 1 |
| K122281 | PADNET 2.0 | Biomedix, Inc. | 2012-08-29 | 30 | 0 |
| K073146 | PADNET+ | Biomedix, Inc. | 2007-11-21 | 13 | 0 |
| K050182 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | Biomedix, Inc. | 2005-08-09 | 194 | 0 |
| K042616 | BIOMEDIX PADNET LAB | Biomedix, Inc. | 2004-10-12 | 19 | 0 |
| K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | Biomedix, Inc. | 2004-05-21 | 184 | 0 |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Biomedix, Inc. | 1997-12-29 | 81 | 0 |
| K973644 | FLOSTAT VASCULAR LAB | Biomedix, Inc. | 1997-12-23 | 90 | 0 |
| K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-1 | Biomedix, Inc. | 1996-09-16 | 122 | 0 |
| K925645 | SELEC-3 | Biomedix, Inc. | 1993-09-27 | 322 | 0 |
| K926498 | ENDOGRIP | Biomedix, Inc. | 1993-04-07 | 99 | 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