Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JSM — Predicate Candidate Screening
111 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
335 days90th percentile
111clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collect | Medical Wire & Equipment Company (Bath), Ltd. | 2025-11-26 | 426 | 0 |
| K250205 | Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co., Ltd. | 2025-09-22 | 241 | 0 |
| K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 | 218 | 0 |
| K232565 | UriSponge™ | Copan Italia Spa | 2024-10-11 | 414 | 0 |
| K220908 | Ensol EnTM Specimen Collection and Transport System | Ensol Biosciences, Inc. | 2024-08-29 | 884 | 0 |
| K240235 | OmniTrans Transport System | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2024-08-19 | 203 | 0 |
| K233534 | Viral Transport Medium | Hardy Diagnostics | 2024-08-02 | 273 | 0 |
| K233449 | Avantik VTM | Hanchang Medic Co., Ltd. (Han Chang Medic) | 2024-07-15 | 269 | 0 |
| K232454 | Viral Transport Media (VTM) | Alb Luz | 2024-05-03 | 263 | 0 |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa | 2024-04-25 | 262 | 0 |
| K202531 | Azer Scientific Universal Transport Medium | Azer Scientific, Inc. | 2024-04-11 | 1318 | 0 |
| K231843 | ARX Viral Transport Media Collection and Transport System | Arx Sciences, Inc. | 2024-03-19 | 271 | 0 |
| K231027 | KaiBiLi Extended ViralTrans | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | 2023-12-21 | 254 | 0 |
| K212743 | MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/ | Medschenker, Inc. | 2023-05-03 | 611 | 0 |
| K230035 | BioSci™ Disposable Virus Sampling Tubes | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-04-05 | 90 | 0 |
| K220052 | Copan FecalSwab Collection, Transport and Preservation Syste | Copan Italia Spa | 2022-12-16 | 344 | 0 |
| K220739 | Disposable Urine Collection Tube | Zhejiang Gongdong Medical Technology Co., Ltd. | 2022-11-17 | 248 | 0 |
| K212856 | iClean Viral Transport System (VTM-RT kit) | Huachenyang (Shenzhen) Technology Co. , Ltd. | 2022-08-18 | 344 | 0 |
| K211256 | Disposable Sampler Viral Transport Media | Wuxi Nest Biotechnology Co., Ltd. | 2022-05-20 | 389 | 0 |
| K211707 | BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd. | 2022-05-04 | 335 | 0 |
| K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | 2021-03-03 | 257 | 0 |
| K180052 | UriSwab-Urine Collection, Transport and Preservation System | Copan Italia Spa | 2018-03-23 | 74 | 0 |
| K163436 | Greiner Vacuette Urine Count and Culture, Mannitol tube | Greiner Bio-One Na, Inc. | 2017-03-06 | 89 | 0 |
| K162284 | Puritan Fecal Opti-Swab Collection and Transport System | Puritan Medical Products, LLC | 2016-11-04 | 81 | 0 |
| K160082 | Puritan Opti-Tranz Cary-Blair Collection and Transport Syste | Puritan Medical Products, LLC | 2016-07-29 | 196 | 0 |
| K150887 | Para-Fix C&S Medium | Medical Chemical Corporation | 2015-05-29 | 57 | 0 |
| K142094 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTE | Copan Italia Spa | 2015-04-10 | 252 | 0 |
| K141506 | MCC Para-Fix CARY BLAIR MEDIUM | Medical Chemical Corporation | 2015-02-25 | 264 | 0 |
| K142366 | Puritan OptiTranz Liquid Stuart Collection and Transport Sys | Puritan Medical Products, LLC | 2015-01-09 | 137 | 0 |
| K113249 | TRANSPORT CULTURE MEDIUM DEVICE | Puritan Medical Products, LLC | 2012-03-01 | 119 | 0 |
| K042970 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM | Copan Diagnostics, Inc. | 2004-12-07 | 40 | 0 |
| K032246 | MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT | Starplex Scientific, Inc. | 2003-08-13 | 22 | 0 |
| K024237 | URINE MONOVETTE BORIC ACID | Sarstedt, Inc. | 2003-04-14 | 112 | 0 |
| K024240 | BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND | Bd | 2003-03-26 | 93 | 3 |
| K001780 | COPAN VIRAL TRANSYSTEM | Copan Diagnostics, Inc. | 2001-07-31 | 413 | 0 |
| K993812 | CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRA | Hardy Diagnostics | 1999-12-21 | 41 | 0 |
| K972726 | SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Medical Packaging Corp. | 1997-10-08 | 79 | 0 |
| K970597 | CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TR | Medical Packaging Corp. | 1997-03-24 | 34 | 0 |
| K965149 | A.C.T. I | Remel Co. | 1997-01-22 | 30 | 0 |
| K965152 | A.C.T. II | Remel Co. | 1997-01-22 | 30 | 1 |
| K965151 | A.C.T. III | Remel Co. | 1997-01-22 | 30 | 0 |
| K965150 | A.C.T. IV | Remel Co. | 1997-01-22 | 30 | 0 |
| K964637 | CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDI | Medical Packaging Corp. | 1996-12-24 | 35 | 0 |
| K961046 | 10B ARGININE BROTH | Remel, L.P. | 1996-09-18 | 187 | 0 |
| K962843 | MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | Starplex Scientific, Inc. | 1996-09-18 | 58 | 0 |
| K955451 | CVM TRANSPORT | Hardy Diagnostics | 1996-07-22 | 236 | 0 |
| K946288 | COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM | Copan Diagnostics, Inc. | 1995-03-10 | 73 | 0 |
| K946286 | COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM | Copan Diagnostics, Inc. | 1995-03-10 | 73 | 0 |
| K946285 | COPAN VENTURI TRANSYSTEM STUARTS MEDIUM | Copan Diagnostics, Inc. | 1995-03-10 | 73 | 0 |
| K946283 | COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM | Copan Diagnostics, Inc. | 1995-03-10 | 73 | 1 |
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