CAF · Nebulizer (Direct Patient Interface)

Device class

Class II

Regulation 868.5630

Total clearances

2020-01-23 → 2026-09-18

Last 12 months

Unique sponsors

Classification details

Medical specialty

Anesthesiology

Review panel

Regulation number

868.5630

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
Adherium (Nz), Ltd.	4	0	2023-02-08
Pari Respiratory Equipment, Inc.	3	1	2025-12-19
Trudell Medical International	2	0	2021-06-14
Hcmed Innovations Co., Ltd.	2	0	2025-06-20
Medline Industries, LP	2	0	2024-01-04
Ochsner Clinic Foundation	1	0	2023-08-30
Dongguan Simzo Electronic Technology Co., Ltd.	1	0	2023-11-27
Monaghan Medical Corporation	1	0	2023-08-24
FindAir Sp. z o.o.	1	1	2026-06-02
Vapotherm, Inc.	1	0	2022-10-28
Feellife Health, Inc.	1	0	2020-09-27
The Ritedose Corporation	1	0	2021-12-03
Joytech Healthcare Co. , Ltd.	1	0	2025-07-02
Qingdao Future Medical Technology Co., Ltd.	1	1	2025-11-14
Aerogen, Ltd.	1	0	2024-05-10
Thayer Medical Corporation	1	0	2024-06-18
Shenzhen Ivankaca Technology Co., Ltd.	1	0	2021-06-14
Fisher & Paykel Healthcare Limited	1	0	2021-12-10
Enchant Tek Co. , Ltd.	1	0	2025-04-29
Voluntis	1	0	2025-06-30
Shenzhen Jermei Medical Device Technology Co., Ltd.	1	0	2025-09-19
Mankind Pharma Limited	1	0	2024-04-10
Reciprocal Labs Corporation	1	0	2020-03-26
Medline Industires, Inc.	1	0	2023-06-23
Excellentcare Medical (Huizhou) , Ltd.	1	0	2021-07-08

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.

Code	Type	Description	Confidence	Rationale
94060	CPT	—	Medium	Nebulizer treatment/inhalation therapy; covers direct patient interface nebulizer
E0580	HCPCS	Nebulizer, durable, glass or autoclavable plastic, bottle type, for use with regulator or flowmeter ✓ CMS-verified description	Medium	Nebulizer, durable medical equipment code for rental

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-18	K254171	Shenzhen Mericonn Technology Co., Ltd.	Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
2026-06-02	K260270	FindAir Sp. z o.o.	FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
2025-12-19	K251572	Pari Respiratory Equipment, Inc.	eRapid with eTrack System
2025-11-14	K251659	Qingdao Future Medical Technology Co., Ltd.	Mesh Nebulizer (H6)
2025-09-19	K244035	Shenzhen Jermei Medical Device Technology Co., Ltd.	Portable mesh nebulizer (JM821)
2025-07-02	K243468	Joytech Healthcare Co. , Ltd.	Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
2025-06-30	K250022	Voluntis	HeroTracker Sense
2025-06-20	K250583	Hcmed Innovations Co., Ltd.	AdheResp Smart Breath-actuated Mesh Nebulizer
2025-04-29	K242354	Enchant Tek Co. , Ltd.	AllNEB
2024-06-18	K233553	Thayer Medical Corporation	MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
2024-05-10	K232507	Aerogen, Ltd.	Aerogen®Solo Nebulizer System
2024-04-10	K232523	Mankind Pharma Limited	Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
2024-01-04	K231058	Medline Industries, LP	Hudson RCI® AddiPak® Unit Dose Vial
2023-11-27	K230379	Dongguan Simzo Electronic Technology Co., Ltd.	Portable (Ultrasonic) Nebulizer
2023-10-31	K230602	Medline Industries, LP	Hudson RCI® TurboMist Nebulizer System
2023-08-30	K223367	Ochsner Clinic Foundation	Ochsner Connected Inhaler Sensor
2023-08-24	K220145	Monaghan Medical Corporation	Monaghan medical filtered mouthpiece kit
2023-08-11	K223840	Pari Respiratory Equipment, Inc.	eRapid Nebulizer System
2023-06-27	K223100	Medline Industries, Inc.	Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
2023-06-23	K220955	Medline Industires, Inc.	Hudson RCI Variable concentration Large Volume Nebulizer (1770)
2023-02-08	K222247	Adherium (Nz), Ltd.	Hailie Sensor NF0110
2022-10-28	K220869	Vapotherm, Inc.	Vapotherm Aerosol Adapter AAA-2
2022-10-04	K221994	Adherium (Nz), Ltd.	Hailie Sensor NF0107 & NF0108
2022-07-15	K220622	Adherium (Nz), Ltd.	Hailie Sensor NF0106
2022-03-25	K212395	Shenzhen Homed Medical Device Co., Ltd.	Nebulizer