Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mds Laboratories, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
154 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864242 | HEKTOEN ENTERIC AGAR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864247 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864254 | THIOGLYCOLLATE BROTH | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864243 | MACCONKEY AGAR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864256 | TRYPTONE WATER (1%) | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864241 | DNASE AGAR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864249 | NORMAL SALINE STERILE | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864240 | COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864255 | TRYPTICASE SOY BROTH | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864250 | SABOURAUD DEXTROSE AGAR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864246 | MUELLER HINTON AGAR LARGE | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864253 | THAYER MARTIN AGAR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864248 | MUELLER HINTON AGAR - SUPPLEMENTED | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864251 | SELENITE F. BROTH | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864252 | THAYER-MARTIN JEMBEC | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864238 | CHOCOLATE AGAR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864237 | CARY BLAIR TRANSPORT MEDIUM | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864244 | GARNERELLA VAGINALIS IDENTIFICATION KIT | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864245 | MUELLER HINTON AGAR SMALL | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864239 | CLED AGAR WITH ANDRADES INDICATOR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K821040 | RAPID SST | Mds Laboratories, Inc. | 1982-05-03 | 20 | 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