# MOD: Accessory To Continuous Ventilator (Respirator)

- Device class: 2; regulation: 21 CFR 868.5895; FDA's rule: 510(k) required
- FDA decisions: 16
- 510(k) review time 2021–2025: median 272 days (middle half 272–272)
- Recalls: 2 (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)
- 1996: 1
- 2001: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2005: 2
- 2009: 1
- 2017: 1
- 2025: 1
- 2026: 3

## Most-cited predicates
- K011861: Bernoulli Ventilator Management System (2001), cited by 2
- K935788: Bicore Smartcath Intratracheal Catheter (1995), cited by 2
- K091461: Bernoulli Management System, Oxinet Iii and Lifegard Vue (2009), cited by 2
- K963633: Ventnet; Central Monitoring Station (1996), cited by 1
- K161411: Care Cycle Connect Application (2017), cited by 1

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