# JSM: Culture Media, Non-Propagating Transport

- Device class: 1; regulation: 21 CFR 866.2390; FDA's rule: 510(k) required
- FDA decisions: 111
- 510(k) review time 2021–2025: median 271 days (middle half 254–389)
- Recalls: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2015: 4
- 2016: 2
- 2017: 1
- 2018: 1
- 2021: 1
- 2022: 5
- 2023: 3
- 2024: 9
- 2025: 3

## Most-cited predicates
- K042970: Copan Universal Transport Medium (Utm-RT) System (2004), cited by 14
- K932337: Culture-Pak Collection and Transport System (1994), cited by 3
- K936078: Culture-Pak Collection/Transport System, Modified (1994), cited by 3
- K854986: BBL Port-a-Cul Aerobic Transport Sys, Modified Stu (1986), cited by 3
- K142094: Copan Fecalswab Collection, Transport and Preservation System (2015), cited by 3
- K024240: BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits (2003), cited by 3
- K946286: Copan Venturi Transystem Cary-Blair Medium (1995), cited by 2
- K180052: UriSwab-Urine Collection, Transport and Preservation System (2018), cited by 2
- K212856: iClean Viral Transport System (VTM-RT kit) (2022), cited by 2
- K201674: Cultura Collection and Transport System (2021), cited by 2

Source page: https://510kreport.com/product-code/JSM
Data by year (CSV): https://510kreport.com/product-code/JSM.csv