Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JTZ · Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
134 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132491 | MUELLER HINTON AGAR | Edge Biologicals, Inc. | 2014-06-30 | 326 | 0 |
| K963036 | MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE B | Becton Dickinson Microbiology Systems | 1996-10-07 | 63 | 0 |
| K960420 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Becton Dickinson Microbiology Systems | 1996-04-04 | 66 | 0 |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | Remel, L.P. | 1996-03-25 | 63 | 0 |
| K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HI | Bioclinical Systems, Inc. | 1995-04-04 | 123 | 0 |
| K941985 | MUELLER HINTON AGAR W/OXACILLIN | Carr-Scarborough Microbiologicals, Inc. | 1994-08-24 | 121 | 0 |
| K882351 | MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 | Lakewood Biochemical Co., Inc. | 1988-06-28 | 21 | 0 |
| K880105 | MULLER HINTON BROTH | Hardy Media | 1988-03-30 | 84 | 0 |
| K873268 | MUELLER HINTON MEDIA | Central Media | 1987-11-04 | 85 | 0 |
| K870649 | MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) | Hardy Media | 1987-04-14 | 60 | 0 |
| K871097 | CHOCOLATE MUELLER HINTON AGAR | bioMerieux, Inc. | 1987-04-03 | 16 | 0 |
| K864247 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864246 | MUELLER HINTON AGAR LARGE | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864248 | MUELLER HINTON AGAR - SUPPLEMENTED | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864245 | MUELLER HINTON AGAR SMALL | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K863821 | MUELLER HINTON AGAR W/4%NACL AND OXACILLIN | Gibco Laboratories Life Technologies, Inc. | 1986-10-09 | 9 | 1 |
| K861301 | BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 | Troy Biologicals, Inc. | 1986-04-21 | 14 | 0 |
| K854521 | BIOGRAM | Giles Scientific, Inc. | 1985-12-23 | 41 | 0 |
| K854451 | MUELLER HINTON MEDIUM | R. Kent Richards, Inc. | 1985-11-18 | 13 | 0 |
| K853238 | APL MUELLER HINTON AGAR | Apl Medical Supplies | 1985-08-19 | 18 | 0 |
| K851225 | URINE DUO | Culture Kits, Inc. | 1985-08-13 | 140 | 0 |
| K850291 | MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS | Remel Co. | 1985-05-10 | 106 | 1 |
| K851589 | MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE | Preferred Micro-Media | 1985-04-30 | 14 | 0 |
| K851518 | MUELLER HINTON SENSITIVITY PLATE | Culture Kits, Inc. | 1985-04-29 | 14 | 0 |
| K850715 | MUELLER HINTON AGAR | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850843 | MUELLER HINTON CHOCOLATE AGAR | Micro Media Laboratories | 1985-03-20 | 19 | 0 |
| K850731 | CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850553 | MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC | Hardy Media | 1985-03-11 | 28 | 0 |
| K844892 | SLT 220 WASHER FOR MICROITITERPLATES | Slt Labinstruments, Inc. | 1985-02-25 | 70 | 0 |
| K842854 | MUELLER HINTON BROTH | Anarobe Systems | 1984-08-17 | 28 | 0 |
| K841834 | CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP | Microline Scientific | 1984-05-14 | 27 | 0 |
| K841755 | MUELLER-HINTON AGAR | The Montana Deaconess Medical Center | 1984-05-14 | 17 | 0 |
| K841560 | MUELLER-HINTON BROTH | Gibco Laboratories Life Technologies, Inc. | 1984-05-07 | 20 | 0 |
| K840969 | CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP | Chatham Biological | 1984-04-13 | 38 | 0 |
| K841213 | ANTIMICROBIAL SUSCEPT-CULTURE MEDIA | Smith River Biologicals | 1984-04-04 | 23 | 0 |
| K841138 | MUELLER HINTON AGAR W/BLOOD & COFACTOR | Anaerobe Systems | 1984-04-04 | 19 | 0 |
| K841137 | MUELLER HINTON AGAR W/WO BLOOD | Anaerobe Systems | 1984-03-26 | 10 | 0 |
| K840066 | CHOCOLATE AGAR MUELLERH-HINTON BASE | Otisville Biotech, Inc. | 1984-02-13 | 35 | 0 |
| K834421 | MUELLER-HINTON AGAR PLATE | Otisville Biotech, Inc. | 1984-02-03 | 50 | 0 |
| K833861 | MUELLER HINTON AGAR | American Biomedical Corp. | 1983-12-08 | 31 | 0 |
| K833506 | PREPARED MUELLER HINTON MED/100 MM | Lavco Laboratory, Inc. | 1983-12-01 | 51 | 0 |
| K832243 | CULTURE MEDIUM FOR ANTIMICROBIAL SUS | Carroll Biological Corp. | 1983-09-29 | 83 | 0 |
| K830060 | MUELLER HINTON | bioMerieux, Inc. | 1983-02-09 | 29 | 0 |
| K822119 | ACCESSORY MEDIA FOR FLOW TITERTEK MIC | Flow Laboratories, Inc. | 1982-08-03 | 15 | 0 |
| K821607 | MUELLER HINTON W/5% SHEEP'S BLOOD | Hardy Media | 1982-07-06 | 39 | 0 |
| K821430 | MUELLER HINTON MEDIUM | Interstate Media | 1982-06-01 | 20 | 0 |
| K821429 | MUELLER HINTON MED. W/5% SHEEP BLOOD | Interstate Media | 1982-06-01 | 20 | 0 |
| K821428 | MUELLER HINTON CHOCOLATE MED. ENRICHED | Interstate Media | 1982-06-01 | 20 | 0 |
| K820846 | ANTIMICROBIAL SUSCEP. TEST, MUELLER | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820794 | #19012 CHOCOLATE MUELLER HINTON-150X15MM | 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