Flex-Cup Percussor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K892862 ↗

FDA Product Code

BYI

Device Class

Class II

Regulation

21 CFR Part 868.5665

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Headstrap

  Class I

  FDA 510(k) K854537 Active Cleared 3 Dec 1985

• Modified Cushion-Flex(Tm)

  Class I

  FDA 510(k) K890108 Active Cleared 24 Jan 1989

• Modification Manual Pulmon Resuscitor/Pulmanex(Tm)

  Class II

  FDA 510(k) K913714 Active Cleared 1 Dec 1992

• Flow Generator for Sleep Apnea, Lds 1500

  Class II

  FDA 510(k) K862448 Active Cleared 14 Nov 1986

• Pulmanex

  Class II

  FDA 510(k) K854037 Active Cleared 1 Nov 1985

• Cushion Flex(Tm)

  Class I

  FDA 510(k) K884387 Active Cleared 17 Nov 1988

See all devices from Life Design Systems, Inc. →

• What is the Flex-Cup Percussor used for in medical procedures?

  The Flex-Cup Percussor is designed to assist in anesthesiology by delivering mechanical percussion through controlled rhythmic vibrations. This helps loosen secretions or facilitate airway clearance during procedures where percussion therapy is required, improving patient comfort and procedural efficiency.

• Is the Flex-Cup Percussor a single-use or reusable device?

  The Flex-Cup Percussor is supplied as a reusable medical instrument. It is intended for repeated use in clinical settings, provided proper maintenance and cleaning protocols are followed to ensure safety and functionality.

• What regulatory pathway does the Flex-Cup Percussor follow?

  The Flex-Cup Percussor holds an FDA 510(k) clearance under the Traditional pathway, with a clearance number of K892862. It is classified as a Class II device under FDA regulation 868.5665 and is associated with the product code BYI, indicating its intended use in anesthesiology.

• Are there any specific storage requirements for the Flex-Cup Percussor?

  While the provided data does not specify detailed storage requirements, reusable medical devices like the Flex-Cup Percussor should generally be stored in a clean, dry environment, protected from moisture and extreme temperatures. Follow manufacturer guidelines for optimal preservation and to prevent contamination or damage.

• Does the Flex-Cup Percussor have any special considerations for use in clinical settings?

  The Flex-Cup Percussor is intended for use in clinical settings where percussion therapy is required, particularly in anesthesiology. Since it is a powered-electric device, ensure proper electrical safety protocols are followed, including grounding and inspection of cords. The device is not explicitly noted for MRI safety, so caution should be exercised when used in or near MRI environments.