Chrysalis Intelligence · Product Codes · NHJ

NHJ · Unclassified

7 clearances · 4 unique sponsors

Device class
Regulation —
Total clearances
7
2020-02-14 → 2026-06-16
Last 12 months
1
Unique sponsors
4
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Abmrc, LLC 3 0 2024-04-08
Hill-Rom Services Pte, Ltd. 2 0 2020-05-26
Hunan Ruijiong Biotech Co., Ltd. 1 1 2026-06-16
Breas Medical AB 1 0 2025-05-16
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
94002 CPT High Ventilation assist and management, initial setup of intermittent positive pressure breathing
E0601 HCPCS Continuous positive airway pressure (cpap) device ✓ CMS-verified description High IPPB (intermittent positive pressure breathing) device
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-16 K253001 Hunan Ruijiong Biotech Co., Ltd. KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
2025-05-16 K242438 Breas Medical AB Clearo
2024-04-08 K231728 Abmrc, LLC BiWaze Clear System
2022-12-21 K213564 Abmrc, LLC BiWaze Clear System
2020-05-26 K200988 Hill-Rom Services Pte, Ltd. Maximus System
2020-03-27 K191912 Abmrc, LLC BiWaze Cough
2020-02-14 K192143 Hill-Rom Services Pte, Ltd. Maximus System