# DQD: Stethoscope, Electronic

- Device class: 2; regulation: 21 CFR 870.1875; FDA's rule: 510(k) required
- FDA decisions: 157
- 510(k) review time 2021–2025: median 136 days (middle half 104–201)
- 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: 4
- 2018: 4
- 2019: 4
- 2020: 6
- 2021: 4
- 2022: 8
- 2023: 10
- 2024: 4
- 2025: 3
- 2026: 6

## Most-cited predicates
- K083903: 3M Littmann Electronic Stethoscope, Model 3200 (2009), cited by 17
- K200776: Eko CORE (2020), cited by 8
- K181612: Tyto Stethoscope (OTC) (2018), cited by 6
- K991367: Meditron Stethoscope System (1999), cited by 6
- K990809: Cadiscope Electronic Stethoscope (1999), cited by 6
- K961848: 3M Littmann Electronic Stethoscope (1997), cited by 5
- K961301: E-Scope Electronic Stethoscope Model 718-7120 (1996), cited by 5
- K003723: 3M Littmann (2001), cited by 5
- K034046: RNK Telephonic Stethoscope, Model TR-1 (2004), cited by 4
- K151319: Eko Electronic Stethoscope System (2015), cited by 4

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