Atlas FDA

JSM

111 FDA 510(k) clearances · Product code

73 daysmedian time to decision
335 days90th percentile
111clearances measured

FDA profile

Official device name
Culture Media, Non-Propagating Transport
Device class
Class I (low risk)
Regulation
21 CFR 866.2390
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 47 · 2021: 42 · 2022: 36 · 2023: 48 · 2024: 21 · 2025: 65
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device (K242976)Medical Wire & Equipment Company (Bath), Ltd.2025-11-26
Babio® Virus Transport Kit (Non-inactivating) (K250205)Jinan Babio Biotechnology Co., Ltd.2025-09-22
AllTest Viral Transport Medium (K242576)Hangzhou AllTest Biotech Co., Ltd.2025-04-04
UriSponge™ (K232565)Copan Italia Spa2024-10-11
Ensol EnTM Specimen Collection and Transport System (K220908)Ensol Biosciences, Inc.2024-08-29
OmniTrans Transport System (K240235)Shenzhen Dakewe Bio-Engineering Co., Ltd.2024-08-19
Viral Transport Medium (K233534)Hardy Diagnostics2024-08-02
Avantik VTM (K233449)Hanchang Medic Co., Ltd. (Han Chang Medic)2024-07-15
Viral Transport Media (VTM) (K232454)Alb Luz2024-05-03
Copan Universal Transport Medium (UTM-RT) System (K232357)Copan Italia Spa2024-04-25
Azer Scientific Universal Transport Medium (K202531)Azer Scientific, Inc.2024-04-11
ARX Viral Transport Media Collection and Transport System (K231843)Arx Sciences, Inc.2024-03-19
KaiBiLi Extended ViralTrans (K231027)Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.2023-12-21
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System (K212743)Medschenker, Inc.2023-05-03
BioSci™ Disposable Virus Sampling Tubes (K230035)Shenzhen Dakewe Bio-Engineering Co., Ltd.2023-04-05
Copan FecalSwab Collection, Transport and Preservation System (K220052)Copan Italia Spa2022-12-16
Disposable Urine Collection Tube (K220739)Zhejiang Gongdong Medical Technology Co., Ltd.2022-11-17
iClean Viral Transport System (VTM-RT kit) (K212856)Huachenyang (Shenzhen) Technology Co. , Ltd.2022-08-18
Disposable Sampler Viral Transport Media (K211256)Wuxi Nest Biotechnology Co., Ltd.2022-05-20
BioTeke Sterile Disposable Virus Sampling Kit (K211707)Bioteke Corporation (Wuxi) Co., Ltd.2022-05-04
Cultura Collection and Transport System (K201674)Merit Medical Systems, Inc.2021-03-03
UriSwab-Urine Collection, Transport and Preservation System (K180052)Copan Italia Spa2018-03-23
Greiner Vacuette Urine Count and Culture, Mannitol tube (K163436)Greiner Bio-One Na, Inc.2017-03-06
Puritan Fecal Opti-Swab Collection and Transport System (K162284)Puritan Medical Products, LLC2016-11-04
Puritan Opti-Tranz Cary-Blair Collection and Transport System (K160082)Puritan Medical Products, LLC2016-07-29
Para-Fix C&S Medium (K150887)Medical Chemical Corporation2015-05-29
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K142094)Copan Italia Spa2015-04-10
MCC Para-Fix CARY BLAIR MEDIUM (K141506)Medical Chemical Corporation2015-02-25
Puritan OptiTranz Liquid Stuart Collection and Transport System (K142366)Puritan Medical Products, LLC2015-01-09
TRANSPORT CULTURE MEDIUM DEVICE (K113249)Puritan Medical Products, LLC2012-03-01
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM (K042970)Copan Diagnostics, Inc.2004-12-07
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K032246)Starplex Scientific, Inc.2003-08-13
URINE MONOVETTE BORIC ACID (K024237)Sarstedt, Inc.2003-04-14
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS (K024240)Bd2003-03-26
COPAN VIRAL TRANSYSTEM (K001780)Copan Diagnostics, Inc.2001-07-31
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K (K993812)Hardy Diagnostics1999-12-21
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (K972726)Medical Packaging Corp.1997-10-08
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) (K970597)Medical Packaging Corp.1997-03-24
A.C.T. I (K965149)Remel Co.1997-01-22
A.C.T. II (K965152)Remel Co.1997-01-22
A.C.T. III (K965151)Remel Co.1997-01-22
A.C.T. IV (K965150)Remel Co.1997-01-22
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA (K964637)Medical Packaging Corp.1996-12-24
10B ARGININE BROTH (K961046)Remel, L.P.1996-09-18
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K962843)Starplex Scientific, Inc.1996-09-18
CVM TRANSPORT (K955451)Hardy Diagnostics1996-07-22
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM (K946288)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM (K946286)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM (K946285)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM (K946283)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K946284)Copan Diagnostics, Inc.1995-03-10
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K946287)Copan Diagnostics, Inc.1995-03-10
KULTSURE STARSWAB(M240), MODIFICATION (K943499)Ncs Diagnostics, Inc.1994-11-30
KULTSURE STARSWAB (M210), MODIFICATION (K943498)Ncs Diagnostics, Inc.1994-11-30
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5) (K941579)Microtest1994-10-21
CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED (K936078)Medical Packaging Corp.1994-08-16
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM (K932337)Medical Packaging Corp.1994-08-16
FLEXTRANS (K935987)Baxter Diagnostics, Inc.1994-08-15
SPECIMEN TRANSPORT MEDIUM (K935618)Biowhittaker Molecular Applications, Inc.1994-04-21
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT (K931922)Viratest Intl., Inc.1994-03-30
M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION) (K921472)Microtest1992-05-06
VIRAPURE, CHLAMYPURE AND MYCOPURE (K914894)Microtest1991-12-18
AEROBIC FOAM SWAB CULTURETTE(R) (K913789)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-09
BACTI-SWAB (K910180)Remel Co.1991-05-10
MICROTEST MULTI MICROBE MEDIUM (K910526)Microtest1991-04-09
CARY-BLAIR TRANSPORT SYSTEM (K885245)Precision Biologicals, Inc.1989-03-21
SAF FECAL COLLECTION KIT (K885244)Precision Biologicals, Inc.1989-03-21
CULTURE COLLECTION DEVICE (K881105)Medical Packaging Corp.1988-04-25
AMIES TRANSPORT MEDIUM (K881539)Acumedia Manufacturers, Inc.1988-04-18
CARY AND BLAIR TRANSPORT MEDIUM (K881529)Acumedia Manufacturers, Inc.1988-04-18
STUARTS TRANSPORT MEDIUM (K881569)Acumedia Manufacturers, Inc.1988-04-18
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (K872507)Precision Dynamics Corp.1987-07-09
TRANSTUBE MW176 OT MD176 (K872213)Medical Wire & Equipment Co.1987-06-23
KULTSURE (K871404)Ncs Diagnostics, Inc.1987-04-21
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (K864998)Boots-Celltech Diagnostics, Inc.1987-04-20
CHLAMYDIA & VIRAL TRANSPORT MEDIUM (K871065)R. Kent Richards, Inc.1987-04-14
CARY BLAIR TRANSPORT MEDIUM (K864237)Mds Laboratories, Inc.1987-03-31
PATHFINDER(TM) SPECIMEN COLLECTION KIT (K863682)Kallestad Laboratories, Inc.1986-10-10
BUFFERED GLYCEROL SALINE (K863602)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
CARY-BLAIR TRANSPORT MEDIUM (K863527)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (K863164)Precision Dynamics Corp.1986-08-27
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) (K861080)Difco Laboratories, Inc.1986-04-07
KULTSURE (CULTURE TRANSPORT) (K860178)Ncs Diagnostics, Inc.1986-04-04
KULTSURE (CATALOGUE NO. M240) (K860657)Ncs Diagnostics, Inc.1986-03-04
KULTSURE (CATALOGUE NO. M210) (K860656)Ncs Diagnostics, Inc.1986-03-04
KULTSURE (CATALOGUE NO. M250) (K860658)Ncs Diagnostics, Inc.1986-03-04
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU (K854986)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-01-03
TRANSPORT CULTURE MEDIA (K854715)Hillcrest Biologicals1985-12-23
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM (K854061)Syva Co.1985-10-23
ORTHO VIRAL TRANSPORT (K853500)Ortho Diagnostic Systems, Inc.1985-08-28
AMIES TRANSPORT MEDIA (K850717)Rapid City Regional Hospital, Inc.1985-03-22
CHLAMYDIAL TRANSPORT MEDIA (K850124)Hillcrest Biologicals1985-03-04
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS (K844634)Precision Dynamics Corp.1985-01-30
VIRAL TRANSPORT MEDIA (K844747)Hillcrest Biologicals1985-01-04
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO (K844369)Precision Dynamics Corp.1985-01-04
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT (K844370)Precision Dynamics Corp.1985-01-04
NON PROPAGATING TRANSPORT (K841205)Smith River Biologicals1984-04-04
CHLAMYDIAL TRANSPORT MEDIUM (K834125)Bartels Immunodiagnostic Supplies, Inc.1984-02-13
STERILE SALINE 0.85% (K834315)Hardy Media1984-01-13
WATER W/TWEEN 80 (K834316)Hardy Media1984-01-13
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Every clearance here is in the API, with alerts when new ones post.