Atlas FDA

JTW

43 FDA 510(k) clearances · Product code

29 daysmedian time to decision
56 days90th percentile
43clearances measured

FDA profile

Official device name
System, Transport, Aerobic
Device class
Class I (low risk)
Regulation
21 CFR 866.2900
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 14 · 2018: 32 · 2020: 12 · 2023: 22 · 2024: 37 · 2025: 38
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K121039)Copan Flock Technologies2012-05-25
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM (K061301)Copan Diagnostics, Inc.2006-06-23
GEN-PROBE APTIMA COMBO 2 ASSAY (K022874)Gen-Probe, Inc.2002-09-17
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM (K013819)Sierra Diagnostic, LLC2002-02-28
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (K993161)Copan Diagnostics, Inc.1999-11-09
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (K983244)Trek Diagnostic Systems, Inc.1998-11-30
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (K961148)Difco Laboratories, Inc.1996-04-26
CULTURESWAB TRANSPORT SYSTEM (K934894)Difco Laboratories, Inc.1994-02-22
P AND T MEDIUM (K904773)Gibson Laboratories, Inc.1990-12-04
FDL, INC.'S TRANSPORT SYSTEM (K895187)Fairleigh Dickinson Laboratories, Inc.1989-10-24
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (K882580)Precision Dynamics Corp.1988-07-08
GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT (K872325)Technology Management & Marketing, Inc.1987-08-12
GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT (K872326)Technology Management & Marketing, Inc.1987-08-11
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK (K843341)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-27
URINE TRANSPORT KIT (K843359)Applied Polytechnology, Inc.1984-09-27
CELL-MATICS VIRAL TRANSPORT PACK (K843173)Difco Laboratories, Inc.1984-09-06
BAKTERIETTE-VI-PAK (K840719)Great Lakes Intl.1984-04-04
PRESERV BUFFERED GLYCEROL SALINE (K840991)Preventive Diagnostics Corp.1984-03-23
PRESERV TRANSPORT & CULTURE PACK (K840968)Preventive Diagnostics Corp.1984-03-23
PRESERV CARY BLAIR TRANSPORT PACK (K840990)Preventive Diagnostics Corp.1984-03-23
GONORRHEA TRANSETTE 1 & 3 (K831579)Spectrum Diagnostic, Inc.1983-06-17
CVT VIRAL TRANSPORTS (K830250)Immulok, Inc.1983-02-28
HERPES TRANSETTE (K823443)Spectrum Diagnostic, Inc.1982-12-03
GC TTANSPORT SYSTEM (K811284)Biolog, Inc.1981-06-12
JEMBEC TRANSPORT SYSTEM (K811283)Biolog, Inc.1981-06-12
MINI-TIP CULTURETTE (K803298)Marion Laboratories, Inc.1981-01-12
TRANSETTE SYSTEM/COLLECTION & TRANSP (K802563)Inolex Corp./Div of Biomedical1980-10-31
CULSWAB CAT.#978 & 979 (K802023)Pollak (Intl.), Ltd.1980-09-09
PDC 304 DOUBLE SWAB CULTURE COLLECTION (K791953)Precision Dynamics Corp.1979-10-30
PDC 104 SINGLE SWAB CULTURE COLLECTION (K791924)Precision Dynamics Corp.1979-10-17
URINE CULTURE KIT (K790366)Bd Becton Dickinson Vacutainer Systems Preanalytic1979-04-04
CHAMBER, AEROBIC (K780440)Marion Laboratories, Inc.1978-04-10
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY (K772209)Precision Dynamics Corp.1977-12-20
CULTURE COLLEC. TRANS. SYS., SINGLE WET (K772207)Precision Dynamics Corp.1977-12-20
CULTURE COLLEC. TRANS. SYS., SINGLE WET (K772206)Precision Dynamics Corp.1977-12-09
CULTURE COLLEC. TRANS. SYS., DOUBLE WET (K772210)Precision Dynamics Corp.1977-12-09
CULTURE COLLEC. TRANS. SYS., DOUBLE WET (K772205)Precision Dynamics Corp.1977-12-09
CULTURE COLLEC. TRANS. SYS., SINGLE DRY (K772208)Precision Dynamics Corp.1977-12-09
EPTONE BACK-UP BROTH, VACUTAINER (K771058)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-07-01
PEDIATRIC BLOOD CULTURE BOTTLES (K770957)Gibco Laboratories Life Technologies, Inc.1977-06-14
BOTTLE, BLOOD CULTURE, BI-PHASIC (K770683)Gibco Laboratories Life Technologies, Inc.1977-04-26
BOTTLE, BLOOD CULTURE, SCHAEDLER (K760458)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-09-03
CULTURE TUBE, (VACUTAINER) (K760054)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-08-03

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Every clearance here is in the API, with alerts when new ones post.