# BYE: Attachment, Breathing, Positive End Expiratory Pressure

- Device class: 2; regulation: 21 CFR 868.5965; FDA's rule: 510(k) required
- FDA decisions: 80
- Recalls: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2003: 1
- 2005: 1
- 2007: 1
- 2008: 1
- 2009: 3
- 2010: 1
- 2011: 3
- 2013: 1
- 2014: 2
- 2016: 1

## Most-cited predicates
- K883825: Modified Sanders BI-Papeasy (1988), cited by 5
- K900164: Airway Delivery & Management (Adam) Nasal Ventila. (1990), cited by 4
- K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH (1999), cited by 4
- K013884: Boussignac C.P.a.P. Device (2003), cited by 4
- K902062: Peep Valve (1990), cited by 4
- K923976: Ambu Single Patient Use Peep Valve (1993), cited by 2
- K070416: Neopeep Neonatal Resuscitation Circuit with Peep (2007), cited by 2
- K080256: Pulmodyne CHF Flow Generator System (2008), cited by 2
- K831503: Downs Adjustable Flow Generator (1983), cited by 2
- K983920: Ems Peep Valves- Adjustable (1999), cited by 2

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