Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JTY — Predicate Candidate Screening
83 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
108 days90th percentile
83clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210511 | InTray GC | Biomed Diagnostics Incorporated | 2021-10-20 | 239 | 0 |
| K993033 | INTRAY GC | Biomed Diagnostics, Inc. | 1999-12-16 | 98 | 0 |
| K954986 | GC BASE W/ 1% GCHI | Remel, L.P. | 1996-02-16 | 108 | 1 |
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | Bioclinical Systems, Inc. | 1995-06-30 | 163 | 0 |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | Bioclinical Systems, Inc. | 1994-02-09 | 229 | 0 |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | Bioclinical Systems, Inc. | 1994-02-03 | 223 | 0 |
| K934331 | THAYER MARTIN, MODIFIED PILL POCKET | Hardy Diagnostics | 1993-12-21 | 109 | 0 |
| K934330 | TRANSGROW | Hardy Diagnostics | 1993-12-17 | 105 | 0 |
| K931864 | MARTIN LEWIS WITH LINOCMYCIN | Hardy Diagnostics | 1993-12-15 | 245 | 0 |
| K881527 | CASMAN MEDIUM BASE | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881552 | PROTEOSE NO. 3 AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K871541 | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 | Gibco Laboratories Life Technologies, Inc. | 1987-04-29 | 9 | 0 |
| K864253 | THAYER MARTIN AGAR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864252 | THAYER-MARTIN JEMBEC | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864803 | GC-LECT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-03 | 56 | 0 |
| K864078 | MODIFIED N.Y.C. FERMENTATION MEDIUM BASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-10-31 | 11 | 0 |
| K860384 | BIOTIS MODIFIED THAYER MARTIN | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K854275 | THAYER-MARTIN MEDIUM (MOD) | R. Kent Richards, Inc. | 1985-11-12 | 25 | 0 |
| K853237 | APL MARTIN LEWIS MEDIUM | Apl Medical Supplies | 1985-08-19 | 18 | 0 |
| K851579 | CHOCOLATE MUELLER HINTON AGAR | Preferred Micro-Media | 1985-05-08 | 22 | 0 |
| K851587 | THAYER MARTIN AGAR & MODIFIED THAYER AGAR | Preferred Micro-Media | 1985-04-30 | 14 | 0 |
| K850722 | MARTIN LEWIS AGAR | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850732 | CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850841 | MOD THAYER MARTIN MARTIN LEWIS | Micro Media Laboratories | 1985-03-20 | 19 | 0 |
| K844014 | ONO/CO-TWO (TM) SYSTEMS | Micro-Bio-Logics | 1984-10-31 | 19 | 0 |
| K843817 | BIOTIS MARTIN LEWIS AGAR | Otisville Biotech, Inc. | 1984-10-10 | 12 | 0 |
| K841750 | MARTIN-LEWIS AGAR | The Montana Deaconess Medical Center | 1984-05-31 | 34 | 0 |
| K841833 | CULTURE MEDIUM FOR PATHOGENIC NEISSER | Microline Scientific | 1984-05-14 | 27 | 0 |
| K840970 | CULTURE MEDIUM FOR PATHOGENIC NEISSER | Chatham Biological | 1984-04-13 | 38 | 0 |
| K840067 | THAYER-MARTIN AGAR PLATE | Otisville Biotech, Inc. | 1984-02-13 | 35 | 0 |
| K840065 | CHOCOLATE AGAR GC BASE PLATE | Otisville Biotech, Inc. | 1984-02-13 | 35 | 0 |
| K840159 | GC-TECT | Uti-Tect, Inc. | 1984-01-30 | 17 | 0 |
| K833862 | THAYER MARTIN AGAR | American Biomedical Corp. | 1983-12-12 | 35 | 0 |
| K832948 | NYC-GC MEDIA | Otisville Biotech, Inc. | 1983-09-29 | 30 | 0 |
| K832862 | TRANSGROW MEDIUM | Troy Biologicals, Inc. | 1983-09-26 | 34 | 0 |
| K832612 | CHOCOLATE AGAR & THAYER MARTIN AGAR | Carroll Biological Corp. | 1983-09-12 | 66 | 0 |
| K831359 | MODIFIED NEW YORK MEDIUM | Gibco Laboratories Life Technologies, Inc. | 1983-05-18 | 22 | 0 |
| K831268 | TILL-U-TEST G.C. GONOCOCUS SLIDE | Pasco Laboratories, Inc. | 1983-05-13 | 25 | 0 |
| K831124 | BIOCULT - GC CULTURE-PADDLES | Orion Diagnostica, Inc. | 1983-05-09 | 34 | 0 |
| K830062 | MARTIN-LEWIS AGAR | bioMerieux, Inc. | 1983-02-09 | 29 | 0 |
| K830061 | THAYER-MARTIN, MODIFIED | bioMerieux, Inc. | 1983-02-09 | 29 | 0 |
| K823309 | MARTIN & LEMIS AGAR W/VCAT INHIBITOR | Troy Biologicals, Inc. | 1982-12-03 | 28 | 0 |
| K822552 | NY FERMENTATION MEDIA | Gibco Laboratories Life Technologies, Inc. | 1982-09-14 | 22 | 0 |
| K821602 | THAYER MARTIN | Hardy Media | 1982-07-06 | 39 | 0 |
| K821551 | MARTIN-LEWIS/PRONG AGAR | Gibco Laboratories Life Technologies, Inc. | 1982-06-22 | 28 | 0 |
| K820847 | ISOLATION OF PATHOGENIC NEISSERIA | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K812078 | GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) | Abbott Laboratories | 1981-07-23 | 0 | 0 |
| K811645 | THAYER-MARTIN, GC AGAR BASE | Hardy Media | 1981-07-02 | 23 | 0 |
| K811479 | CHODOLATE AGAR, ENRICHED | Biomedia, Inc. | 1981-06-18 | 23 | 0 |
| K811476 | THAYER MARTIN AGAR | Biomedia, Inc. | 1981-06-18 | 23 | 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