# DSH: Recorder, Magnetic Tape, Medical

- Device class: 2; regulation: 21 CFR 870.2800; FDA's rule: 510(k) required
- FDA decisions: 195
- 510(k) review time 2021–2025: median 244 days (middle half 105–271)
- Recalls: 0 (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)
- 2017: 3
- 2018: 3
- 2019: 3
- 2020: 4
- 2021: 4
- 2022: 4
- 2023: 6
- 2024: 2
- 2025: 4
- 2026: 2

## Most-cited predicates
- K020825: King of Hearts Express + AF Monitor (2002), cited by 11
- K143513: ZIO SR ECG Monitoring Service (2015), cited by 9
- K022540: Cardio ID+(RZ153+) (2002), cited by 6
- K163535: my Patch sl (2017), cited by 3
- K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C (2009), cited by 3
- K171410: ePatch (2018), cited by 3
- K231289: S-Patch Ex Wearable ECG Patch (2023), cited by 3
- K001025: Lifecard CF Compact Recorder (2000), cited by 3
- K121319: Zio Patch (2012), cited by 3
- K160704: myPatch-s (2016), cited by 2

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