Percussor

FDA 510(k) K812166 · Dhd Medical Products Div. Diemolding Corp.

Substantially Equivalent

510(k) numberK812166

Submission

Device name
Percussor
Applicant
Dhd Medical Products Div. Diemolding Corp.
Mchenry, IL, US
Received
July 30, 1981
Decision date
August 18, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYI – Percussor, Powered-Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Specialty
Anesthesiology

Other 510(k)s with product code BYI

510(k)DeviceApplicantDecision
K252849AffloVest® Mobile Airway Clearance TherapyBYI · Traditional Tactile Medical04/30/2026SE
K250860BreatheBand® (Model 1000)BYI · Traditional Exemplar Medical, LLC10/02/2025SE
K242063LibAirty Airway Clearance SystemBYI · Traditional Synchrony Medical , Ltd.12/19/2024SE
K240959Respiratory Muscle TrainerBYI · Traditional Chongqing Moffy Innovation Technology Co., Ltd.12/18/2024SE
K233441The Vest APX System (PVAPX1)BYI · Traditional Baxter Healthcare Corportation03/22/2024SE
K222496Electromed SmartVest Airway Clearance SystemBYI · Special Electromed, Inc.11/18/2022SE
K201490Electro Flo 6 Airway Clearance SystemBYI · Traditional Med Systems, Inc.02/12/2021SE
K203209AirPhysio Positive Expiratory Pressure (PEP) DeviceBYI · Traditional Airphysio Pty, Ltd.01/15/2021SE
K173603Monarch Airway Clearance SystemBYI · Traditional Hill-Rom Holdings, Inc.10/24/2018SE
K163378Monarch Airway Clearance SystemBYI · Traditional Hill-Rom Services Pte, Ltd.03/17/2017SE

More from Hill-Rom Services Pte, Ltd.

510(k)DeviceDecision
K883988Non-Rebreathing Tee Piece (NRTP)CBP · Traditional 10/07/1988SE
K881935Microcirrus Medical NebulizerCAF · Traditional 06/22/1988SE
K881178CuffcheckBSK · Traditional 04/14/1988SE
K873498Inspiratory Force Mont Kit/Manifold/Meter/TubingBXR · Traditional 03/09/1988SE
K874047AsthmakitCAF · Traditional 02/29/1988SE
K873447Disposable Condensate Bottle for 7200 VentilatorBYH · Traditional 10/30/1987SE
K860885Straight Connectors, 15MM, 30MM & 19MMBZA · Traditional 03/20/1986SE
K860882Disposable CatheterBZA · Traditional 03/20/1986SE
K860880Ventilator Circuits (Various Types)BZO · Traditional 03/20/1986SE
K860879Disposable Ventilator CircuitsBZO · Traditional 03/20/1986SE

Questions and answers

When was Percussor cleared by the FDA?

Percussor (K812166) received a 510(k) decision of Substantially Equivalent on August 18, 1981, 19 days after the submission was received.

What is the product code of K812166?

The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.