# ORY: Tongue Suspension System

- Device class: 2; regulation: 21 CFR 872.5570; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 85 days (middle half 85–85)
- 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)
- 2010: 2
- 2011: 2
- 2012: 2
- 2014: 1
- 2019: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K110127: Prelude Iii Tongue Suspension System (2011), cited by 2
- K111179: Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue Suspension System System (Monofilamen (2011), cited by 2
- K101060: Siesta Medical, Inc., Prelude Tongue Suspension System (2010), cited by 1
- K121440: Encore Tongue Suspension System Encore Removal-Titration Kit (2012), cited by 1
- K183310: Encore System (2019), cited by 1
- K103179: Prelude II Tounge Suspension System (2010), cited by 1
- K201238: Encore System (2020), cited by 1
- K133680: Encore System (2014), cited by 1

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