Acapella Choice Blue Vibratory PEP Device

Q: What is the product code of K181660?

The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.

FDA 510(k) K181660 · Smiths Medical

Substantially Equivalent

510(k) numberK181660

Submission

Device name: Acapella Choice Blue Vibratory PEP Device
Applicant: Smiths Medical
Plymouth, MN, US
Received: June 25, 2018
Decision date: October 24, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: BWF – Spirometer, Therapeutic (Incentive)
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5690
Specialty: Anesthesiology

Other 510(k)s with product code BWF

510(k)	Device	Applicant	Decision
K241152	InSeeBWF · Traditional	Tidal Medical Technologies, LLC	08/21/2025SE
K233855	AllPEPBWF · Traditional	Enchant Tek Co. , Ltd.	02/02/2024SE
K221058	LungTrainer (MD2 & MD3)BWF · Traditional	Lung Trainers, LLC	07/05/2023SE
K222018	Breathe+BWF · Traditional	Peep Medical, LLC Dba Go2 Devices	06/02/2023SE
K220565	Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional	Medline Industries, Inc.	10/25/2022SE
K203378	PulsehalerBWF · Traditional	Respinova, Ltd.	03/31/2021SE
K192000	D R Burton OxyPAPBWF · Traditional	D R Burton Healthcare, LLC	02/19/2020SE
K183108	Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional	Trudell Medical International	08/16/2019SE
K182847	Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional	Teleflexmedical, Inc.	07/01/2019SE
K173918	VersaPAP Positive Airway Pressure (PAP) DeviceBWF · Traditional	Trudell Medical International	08/17/2018SE

More from Trudell Medical International

510(k)	Device	Decision
K050166	Portex Emergency Cricothyroidotomy KitBWC · Traditional	05/26/2005SE
K041348	Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_With Serial Dilators or Single…JOH · Traditional	07/13/2004SE

Questions and answers

When was Acapella Choice Blue Vibratory PEP Device cleared by the FDA?

Acapella Choice Blue Vibratory PEP Device (K181660) received a 510(k) decision of Substantially Equivalent on October 24, 2019, 486 days after the submission was received.

What is the product code of K181660?

The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.