Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomedica, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
16 daysmedian FDA review time
16 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820801 | #2007 XLD | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820797 | #50001 QUADE DIAGNOSTIC SYSTEM | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820795 | #4006 TSB-TUBED MEDIA | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820794 | #19012 CHOCOLATE MUELLER HINTON-150X15MM | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820810 | #4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820809 | #2008 SIMMONS CITRATE | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820804 | #2013 CNA 5% SHEEP BLOOD | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820807 | #2011 STREP SELECTIVE AGAR | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820803 | #2003 MYCOBIOTIC AGAR | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820791 | #4005 TSA SLANT-TUBED MEDIA | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820799 | #2002 MANNITOL SALT AGAR | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820800 | #2006 SALMONELLA SHIGELLA AGAR | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820802 | #2009 BIGGY AGAR | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820805 | #2005 SABOURAUD DEXTROSE AGAR/#4002 SLA | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820806 | #2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820793 | #1904L MUELLER HINTON W/5% SHEEP BLOOD | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820796 | #4001 TUBED MEDIA - FLUID THIOGLYCOLLATE | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820798 | #2001 HEKTOEN | Biomedica, Inc. | 1982-04-08 | 16 | 0 |
| K820792 | #19041-150X15MM MUELLER HINTON | Biomedica, Inc. | 1982-04-08 | 16 | 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