FDA Product Code JSM: Culture Media, Non-propagating Transport
Leading manufacturers include Remel Co., Bd Becton Dickinson Vacutainer Systems Preanalytic and Copan Italia Spa.
111
Total
111
Cleared
136d
Avg days
1979
Since
Declining activity -
6 submissions in the last 2 years
vs 12 in the prior period
Review times increasing: avg
398d
recently vs 121d historically
FDA 510(k) Cleared Culture Media, Non-propagating Transport Devices (Product Code JSM)
111 devices
Cleared
Nov 26, 2025
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
Medical Wire & Equipment Company (Bath), Ltd.
Microbiology
426d
Cleared
Sep 22, 2025
Babio® Virus Transport Kit (Non-inactivating)
Jinan Babio Biotechnology Co., Ltd.
Microbiology
241d
Cleared
Apr 04, 2025
AllTest Viral Transport Medium
Hangzhou AllTest Biotech Co., Ltd.
Microbiology
218d
Cleared
Oct 11, 2024
UriSponge™
Copan Italia Spa
Microbiology
414d
Cleared
Aug 29, 2024
Ensol EnTM Specimen Collection and Transport System
Ensol Biosciences, Inc.
Microbiology
884d
Cleared
Aug 19, 2024
OmniTrans Transport System
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Microbiology
203d
Cleared
Aug 02, 2024
Viral Transport Medium
Hardy Diagnostics
Microbiology
273d
Cleared
Jul 15, 2024
Avantik VTM
Hanchang Medic Co., Ltd. (Han Chang Medic)
Microbiology
269d
Cleared
May 03, 2024
Viral Transport Media (VTM)
Alb Luz
Microbiology
263d
Cleared
Apr 25, 2024
Copan Universal Transport Medium (UTM-RT) System
Copan Italia Spa
Microbiology
262d
Cleared
Apr 11, 2024
Azer Scientific Universal Transport Medium
Azer Scientific, Inc.
Microbiology
1318d
Cleared
Mar 19, 2024
ARX Viral Transport Media Collection and Transport System
Arx Sciences, Inc.
Microbiology
271d
Cleared
Dec 21, 2023
KaiBiLi Extended ViralTrans
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
Microbiology
254d
Cleared
May 03, 2023
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
Medschenker, Inc.
Microbiology
611d
Cleared
Apr 05, 2023
BioSci™ Disposable Virus Sampling Tubes
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Microbiology
90d
Cleared
Dec 16, 2022
Copan FecalSwab Collection, Transport and Preservation System
Copan Italia Spa
Microbiology
344d
Cleared
Nov 17, 2022
Disposable Urine Collection Tube
Zhejiang Gongdong Medical Technology Co., Ltd.
Microbiology
248d
Cleared
Aug 18, 2022
iClean Viral Transport System (VTM-RT kit)
Huachenyang (Shenzhen) Technology Co. , Ltd.
Microbiology
344d
Cleared
May 20, 2022
Disposable Sampler Viral Transport Media
Wuxi Nest Biotechnology Co., Ltd.
Microbiology
389d
Cleared
May 04, 2022
BioTeke Sterile Disposable Virus Sampling Kit
Bioteke Corporation (Wuxi) Co., Ltd.
Microbiology
335d
Cleared
Mar 03, 2021
Cultura Collection and Transport System
Merit Medical Systems, Inc.
Microbiology
257d
Cleared
Mar 23, 2018
UriSwab-Urine Collection, Transport and Preservation System
Copan Italia Spa
Microbiology
74d
Cleared
Dec 21, 1999
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
Hardy Diagnostics
Microbiology
41d
Cleared
Jan 22, 1997
A.C.T. I
Remel Co.
Microbiology
30d
About Product Code JSM - Regulatory Context
510(k) Submission Activity
111 total 510(k) submissions under product code JSM since 1979, with 111 receiving FDA clearance (average review time: 136 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 12 in the prior period.
FDA 510(k) Review Time - JSM Product Code
Recent submissions under JSM have taken an average of 398 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.
JSM devices are reviewed by the Microbiology panel. Browse all Microbiology devices →