# JWY: Manual Antimicrobial Susceptibility Test Systems

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 442
- 510(k) review time 2021–2025: median 90 days (middle half 86–154)
- Recalls: 48 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 4
- 2017: 14
- 2018: 12
- 2019: 18
- 2020: 5
- 2021: 5
- 2023: 7
- 2024: 6
- 2025: 14
- 2026: 2

## Most-cited predicates
- K963641: Streptococcus Mic Panel (1996), cited by 22
- K020556: Microscan Microstrep Plus Panel with Levofloxacin (2002), cited by 4
- K192355: MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) (2019), cited by 3
- K153687: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL (2016), cited by 3
- K180936: ETEST Telavancin (TLA) (0.002-32 ug/mL) (2018), cited by 3
- K183031: ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (2019), cited by 3
- K992143: Modification to Pasco Mic and Mic/ID Panels (Clindamycin) (1999), cited by 2
- K001953: Pasco Mic and Mic/ID Panels (2000), cited by 2
- K991925: Pasco Mic and Mic/ID Panels (1999), cited by 2
- K030933: Pasco Mic and Mic/ID Panels (2003), cited by 2

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