Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JTW — Predicate Candidate Screening
43 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
56 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121039 | COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | Copan Flock Technologies | 2012-05-25 | 50 | 0 |
| K061301 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANS | Copan Diagnostics, Inc. | 2006-06-23 | 44 | 0 |
| K022874 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2002-09-17 | 53 | 0 |
| K013819 | URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM | Sierra Diagnostic, LLC | 2002-02-28 | 104 | 0 |
| K993161 | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM | Copan Diagnostics, Inc. | 1999-11-09 | 48 | 1 |
| K983244 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPE | Trek Diagnostic Systems, Inc. | 1998-11-30 | 75 | 9 |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | Difco Laboratories, Inc. | 1996-04-26 | 36 | 0 |
| K934894 | CULTURESWAB TRANSPORT SYSTEM | Difco Laboratories, Inc. | 1994-02-22 | 140 | 0 |
| K904773 | P AND T MEDIUM | Gibson Laboratories, Inc. | 1990-12-04 | 43 | 0 |
| K895187 | FDL, INC.'S TRANSPORT SYSTEM | Fairleigh Dickinson Laboratories, Inc. | 1989-10-24 | 74 | 0 |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Precision Dynamics Corp. | 1988-07-08 | 17 | 0 |
| K872325 | GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT | Technology Management & Marketing, Inc. | 1987-08-12 | 56 | 0 |
| K872326 | GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT | Technology Management & Marketing, Inc. | 1987-08-11 | 55 | 0 |
| K843341 | GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-09-27 | 31 | 0 |
| K843359 | URINE TRANSPORT KIT | Applied Polytechnology, Inc. | 1984-09-27 | 31 | 0 |
| K843173 | CELL-MATICS VIRAL TRANSPORT PACK | Difco Laboratories, Inc. | 1984-09-06 | 24 | 0 |
| K840719 | BAKTERIETTE-VI-PAK | Great Lakes Intl. | 1984-04-04 | 47 | 0 |
| K840991 | PRESERV BUFFERED GLYCEROL SALINE | Preventive Diagnostics Corp. | 1984-03-23 | 16 | 0 |
| K840968 | PRESERV TRANSPORT & CULTURE PACK | Preventive Diagnostics Corp. | 1984-03-23 | 17 | 0 |
| K840990 | PRESERV CARY BLAIR TRANSPORT PACK | Preventive Diagnostics Corp. | 1984-03-23 | 16 | 0 |
| K831579 | GONORRHEA TRANSETTE 1 & 3 | Spectrum Diagnostic, Inc. | 1983-06-17 | 31 | 0 |
| K830250 | CVT VIRAL TRANSPORTS | Immulok, Inc. | 1983-02-28 | 34 | 0 |
| K823443 | HERPES TRANSETTE | Spectrum Diagnostic, Inc. | 1982-12-03 | 17 | 0 |
| K811284 | GC TTANSPORT SYSTEM | Biolog, Inc. | 1981-06-12 | 35 | 0 |
| K811283 | JEMBEC TRANSPORT SYSTEM | Biolog, Inc. | 1981-06-12 | 35 | 0 |
| K803298 | MINI-TIP CULTURETTE | Marion Laboratories, Inc. | 1981-01-12 | 13 | 0 |
| K802563 | TRANSETTE SYSTEM/COLLECTION & TRANSP | Inolex Corp./Div of Biomedical | 1980-10-31 | 15 | 0 |
| K802023 | CULSWAB CAT.#978 & 979 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K791953 | PDC 304 DOUBLE SWAB CULTURE COLLECTION | Precision Dynamics Corp. | 1979-10-30 | 29 | 0 |
| K791924 | PDC 104 SINGLE SWAB CULTURE COLLECTION | Precision Dynamics Corp. | 1979-10-17 | 20 | 0 |
| K790366 | URINE CULTURE KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-04-04 | 41 | 1 |
| K780440 | CHAMBER, AEROBIC | Marion Laboratories, Inc. | 1978-04-10 | 21 | 0 |
| K772209 | CULTURE COLLEC. TRANS. SYS., DOUBLE DRY | Precision Dynamics Corp. | 1977-12-20 | 19 | 0 |
| K772207 | CULTURE COLLEC. TRANS. SYS., SINGLE WET | Precision Dynamics Corp. | 1977-12-20 | 19 | 0 |
| K772206 | CULTURE COLLEC. TRANS. SYS., SINGLE WET | Precision Dynamics Corp. | 1977-12-09 | 8 | 0 |
| K772210 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET | Precision Dynamics Corp. | 1977-12-09 | 8 | 0 |
| K772205 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET | Precision Dynamics Corp. | 1977-12-09 | 8 | 0 |
| K772208 | CULTURE COLLEC. TRANS. SYS., SINGLE DRY | Precision Dynamics Corp. | 1977-12-09 | 8 | 0 |
| K771058 | EPTONE BACK-UP BROTH, VACUTAINER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-07-01 | 18 | 0 |
| K770957 | PEDIATRIC BLOOD CULTURE BOTTLES | Gibco Laboratories Life Technologies, Inc. | 1977-06-14 | 18 | 0 |
| K770683 | BOTTLE, BLOOD CULTURE, BI-PHASIC | Gibco Laboratories Life Technologies, Inc. | 1977-04-26 | 14 | 0 |
| K760458 | BOTTLE, BLOOD CULTURE, SCHAEDLER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-09-03 | 17 | 0 |
| K760054 | CULTURE TUBE, (VACUTAINER) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-03 | 48 | 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