Device type
Device, Positive Pressure Breathing, Intermittent
Product code NHJ · Class II · 21 CFR 868.5905 · Anesthesiology
Recent 510(k)s
Aug 24, 2026
K260604
BiWaze Clear System
Abmrc, LLC
- NHJ
- Class II
Recent recalls
Oct 7, 2026
Z-3324-2026
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3322-2026
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3323-2026
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3325-2026
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3321-2026
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3319-2026
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In…
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Sep 30, 2026
Z-3257-2026
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERI…
Baxter Healthcare Corporation
- NHJ
- Class II
- Ongoing