Product code NHJ— Anesthesiology
BiWaze Clear System
- Classification name
- Device, Positive Pressure Breathing, Intermittent
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Total cleared
- 26
- First cleared
- Most recent
Market context for product code NHJ
FDA has cleared devices under product code NHJ between 1978 and 2026, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2022
- 2020
- 2016
- 2014
- 2013
- 2012
- 2008
- 2005
- 2001
- 2000
- 1998
- 1992
Top applicants under product code NHJ
Adverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NHJ
- K260604 — BiWaze Clear System
- K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
- K242438 — Clearo
- K231728 — BiWaze Clear System
- K213564 — BiWaze Clear System
- K200988 — Maximus System
- K191912 — BiWaze Cough
- K192143 — Maximus System
- K151689 — MetaNeb 4 System
- K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
- K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
- K132988 — VITAL COUGH
- K124032 — METANEB
- K113549 — COMFORT COUGH
- K121955 — COUGHASSIST T70 DEVICE
- K120277 — VITAL COUGH
- K072292 — NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS
- K051964 — POWERNEB
- K003684 — PERCUSSIVENEB, MODEL PN-2001
- K002598 — EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
- K982016 — PIPER IPPB MODEL 2055
- K981726 — PERCUSSIVETECH HF, MODEL 2001
- K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA
- K905236 — IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES
- K895485 — BIRD (IPV) NONCONTINUOUS VENTILATORS
- K781232 — IPPB ASSEMBLY W/NEBULIZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.