Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JSH · Predicate Candidate Screening
146 FDA 510(k) clearances under this product code; the 50 most recent screened below.
26 daysmedian FDA review time
49 days90th percentile
146clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881486 | DNASE TEST AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881559 | UREA AGAR BASE | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881553 | RUSSELL DOUBLE SUGAR AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881560 | UREA BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 | 7 | 0 |
| K881551 | PHENOL RED BROTH BASE | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K881540 | FLO AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 | 10 | 0 |
| K880121 | MOELLERS DECARBOXYLASE, BASE | Hardy Media | 1988-03-31 | 85 | 0 |
| K880117 | OF MEDIUM BASE | Hardy Media | 1988-03-30 | 84 | 0 |
| K873270 | ACTINOMYCETE DIFFERENTIAL MEDIA | Central Media | 1987-11-04 | 85 | 0 |
| K873263 | MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA | Central Media | 1987-10-28 | 78 | 0 |
| K873411 | SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 | Lakewood Biochemical Co., Inc. | 1987-10-06 | 43 | 0 |
| K873704 | MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 | Lakewood Biochemical Co., Inc. | 1987-10-02 | 18 | 0 |
| K873703 | LYSINE IRON AGAR (LIA) PRODUCT #T3046 | Lakewood Biochemical Co., Inc. | 1987-10-02 | 18 | 0 |
| K872670 | IAFP MAC CONKEY AGAR | I.A.F. Production, Inc. | 1987-08-11 | 35 | 0 |
| K872020 | MUCATE AGAR, SLANTS AND MUCATE BROTH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-06-02 | 7 | 0 |
| K871855 | SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM | Gibco Laboratories Life Technologies, Inc. | 1987-05-26 | 13 | 0 |
| K871701 | ARYLSULFATASE BROTH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-05-20 | 19 | 0 |
| K870636 | HEMOPHILUS ID QUAD PLATE | Hardy Media | 1987-04-14 | 60 | 0 |
| K870651 | BIGGY AGAR | Hardy Media | 1987-04-14 | 60 | 0 |
| K871095 | CLED AGAR | bioMerieux, Inc. | 1987-04-03 | 16 | 0 |
| K864239 | CLED AGAR WITH ANDRADES INDICATOR | Mds Laboratories, Inc. | 1987-03-31 | 154 | 0 |
| K864454 | THERMOSTABLE NUCLEASE TEST AGAR | Dimed, Intl. | 1986-11-28 | 16 | 0 |
| K864205 | THERMONUCLEASE AGAR W/TOLUIDINE BLUE | Remel Co. | 1986-11-24 | 28 | 0 |
| K864100 | TRYCOPHYTON AGARS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-10-31 | 10 | 0 |
| K863599 | STARCH AGAR W/BROM CRESOL PURPLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 | 15 | 0 |
| K863600 | MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 | 15 | 0 |
| K863572 | XANTHINE/TYROSINE/CASEIN AGAR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 | 18 | 0 |
| K863573 | BIRD SEED AGAR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 | 18 | 0 |
| K863523 | TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-19 | 9 | 0 |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K860750 | PSEUDOMONAS AGAR P (MEDIUM A) | Gibco Laboratories Life Technologies, Inc. | 1986-03-10 | 10 | 0 |
| K853618 | APL SIM MEDIUM | Apl Medical Supplies | 1985-09-16 | 18 | 0 |
| K853610 | APL MOTILITY INDOLE ORNITHINE AGAR | Apl Medical Supplies | 1985-09-16 | 18 | 0 |
| K853619 | APL TRIPLE SUGAR IRON AGAR | Apl Medical Supplies | 1985-09-16 | 18 | 0 |
| K853615 | APL BILE ESCULIN/AZIDE AGAR | Apl Medical Supplies | 1985-09-06 | 8 | 0 |
| K853613 | APL GN BROTH | Apl Medical Supplies | 1985-09-06 | 8 | 0 |
| K853616 | APL CHLAMYDOSPORE AGAR | Apl Medical Supplies | 1985-09-06 | 8 | 0 |
| K853612 | APL DNASE TEST AGAR | Apl Medical Supplies | 1985-09-06 | 8 | 0 |
| K853614 | APL FLUID THIOGLYCOLLATE MEDIUM | Apl Medical Supplies | 1985-09-06 | 8 | 0 |
| K853336 | DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR | Hardy Media | 1985-08-29 | 20 | 0 |
| K852578 | CLED AGAR | American Laboratory Supply, Inc. | 1985-07-12 | 24 | 0 |
| K852064 | DRI-FORM PSEUDOMONAS AGAR F | Gibco Laboratories Life Technologies, Inc. | 1985-06-04 | 22 | 0 |
| K851597 | TRIPLE SUGAR IRON AGAR | Preferred Micro-Media | 1985-05-13 | 27 | 0 |
| K851595 | SIMMONS CITRATE AGAR | Preferred Micro-Media | 1985-05-13 | 27 | 0 |
| K851596 | SIM MEDIUM | Preferred Micro-Media | 1985-05-13 | 27 | 0 |
| K851576 | BIGGY AGAR NICKERSONS MEDIUM | Preferred Micro-Media | 1985-05-09 | 23 | 0 |
| K851602 | UREA AGAR | Preferred Micro-Media | 1985-05-08 | 22 | 0 |
| K851344 | OXIDATIVE FORMENTIVE MEDIUM | Micro Media Laboratories | 1985-04-22 | 18 | 0 |
| K851343 | BROM CRESOL PURPLE STARCH | Micro Media Laboratories | 1985-04-19 | 15 | 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