Chrysalis Intelligence · Product Codes · BZE

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

Anesthesiology · 7 clearances · 6 unique sponsors

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Device class
Class II
Regulation 868.5270
Total clearances
7
2021-01-29 → 2026-06-18
Last 12 months
2
Unique sponsors
6
Classification details
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.5270
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medline Industries, LP 2 1 2026-03-25
Guangdong Eda Technology Co., Ltd. 1 0 2025-07-25
Vincent Healthcare Products Limited 1 1 2026-06-18
Exceleron Medical 1 0 2024-08-02
Sunset Healthcare Solutions, Inc. 1 0 2021-01-29
Draegerwerk AG & CO Kgaa 1 0 2023-06-14
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
E0605 HCPCS Vaporizer, room type ✓ CMS-verified description Medium Heated humidifier/heater for respiratory circuit
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-18 K252066 Vincent Healthcare Products Limited inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)
2026-03-25 K253322 Medline Industries, LP Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
2025-07-25 K243244 Guangdong Eda Technology Co., Ltd. Heated Breathing Tube
2024-08-02 K241268 Exceleron Medical Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
2024-06-04 K234032 Medline Industries, LP Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
2023-06-14 K222822 Draegerwerk AG & CO Kgaa VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
2021-01-29 K201418 Sunset Healthcare Solutions, Inc. Sunset Heated CPAP Tube
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence