GUS831 Compressor Nebulizer

Q: What is the product code of K192633?

The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.

FDA 510(k) K192633 · Globalcare Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK192633

Submission

Device name: GUS831 Compressor Nebulizer
Applicant: Globalcare Medical Technology Co., Ltd.
Xiaolan Town, Zhongshan City, CN
Received: September 23, 2019
Decision date: May 1, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: CAF – Nebulizer (Direct Patient Interface)
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5630
Specialty: Anesthesiology

Other 510(k)s with product code CAF

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K251572	eRapid with eTrack SystemCAF · Traditional	Pari Respiratory Equipment, Inc.	12/19/2025SE
K251659	Mesh Nebulizer (H6)CAF · Traditional	Qingdao Future Medical Technology Co., Ltd.	11/14/2025SE
K244035	Portable mesh nebulizer (JM821)CAF · Traditional	Shenzhen Jermei Medical Device Technology Co.…	09/19/2025SE
K243468	Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…CAF · Traditional	Joytech Healthcare Co. , Ltd.	07/02/2025SE
K250022	HeroTracker SenseCAF · Traditional	Voluntis	06/30/2025SE
K250583	AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional	Hcmed Innovations Co., Ltd.	06/20/2025SE
K242354	AllNEBCAF · Traditional	Enchant Tek Co. , Ltd.	04/29/2025SE
K233553	MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special	Thayer Medical Corporation	06/18/2024SE
K232507	Aerogen®Solo Nebulizer SystemCAF · Traditional	Aerogen, Ltd.	05/10/2024SE

More from Aerogen, Ltd.

510(k)	Device	Decision
K253896	TENS/EMS device (GUSE01)NUH · Traditional	03/04/2026SE
K250136	Globalcare Blood Pressure Monitor (GUS610)DXN · Special	04/08/2025SE
K222160	GUS610 Blood pressure monitorDXN · Traditional	11/22/2022SE
K192609	Globalcare Blood Pressure MonitorDXN · Traditional	04/21/2020SE

Questions and answers

When was GUS831 Compressor Nebulizer cleared by the FDA?

GUS831 Compressor Nebulizer (K192633) received a 510(k) decision of Substantially Equivalent on May 1, 2020, 221 days after the submission was received.

What is the product code of K192633?

The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.