# BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

- Device class: 2; regulation: 21 CFR 868.5270; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 245 days (middle half 167–268)
- 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)
- 2014: 1
- 2015: 1
- 2016: 5
- 2017: 1
- 2018: 1
- 2021: 1
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits (2000), cited by 7
- K103767: Dual Heated Infant Vreathing Cirouits (2012), cited by 6
- K122432: Adult Evaqua 2' Dual Heated Breathing Circuits (2012), cited by 4
- K092129: Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-CH, 2310, 2320, 2330 (2010), cited by 2
- K034026: RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits (2005), cited by 2
- K100104: Hybernite Rainout Control System (2010), cited by 2
- K151461: Hybernite RT (2016), cited by 2
- K140424: Respironics Reusable Heated Tubing (2014), cited by 2
- K110398: Respironics Disposable Heated Wire Circuits (2011), cited by 1
- K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (2023), cited by 1

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