Medical Depot Power Neb 1

Q: What is the product code of K012006?

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) K012006 · Medical Depot, Inc.

Substantially Equivalent

510(k) numberK012006

Submission

Device name: Medical Depot Power Neb 1
Applicant: Medical Depot, Inc.
Appollo Beach, FL, US
Received: June 27, 2001
Decision date: July 13, 2001
Decision: Substantially Equivalent (SESE)
Type: Special 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

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K251659	Mesh Nebulizer (H6)CAF · Traditional	Qingdao Future Medical Technology Co., Ltd.	11/14/2025SE
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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
K080391	Drive Solstice Oxygen ConcentratorCAW · Traditional	03/18/2008SE
K003344	Medical Depot Nebulizer, Model Power Neb 2CAF · Traditional	03/15/2001SE
K003783	Medical Depot-Wheelchairs, Model Sentra,Astaire and ViperIOR · Traditional	01/12/2001SE

Questions and answers

When was Medical Depot Power Neb 1 cleared by the FDA?

Medical Depot Power Neb 1 (K012006) received a 510(k) decision of Substantially Equivalent on July 13, 2001, 16 days after the submission was received.

What is the product code of K012006?

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