# SDT: Intra-Pulmonary Percussive Vibration (Ipv) Devices

- Device class: 2; regulation: 21 CFR 868.5665; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 245 days (middle half 245–245)
- 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)
- 2012: 1
- 2014: 1
- 2024: 1

## Most-cited predicates
- K122111: Respironics Simplyclear Device (2012), cited by 3

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