Therapep

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

510(k) Number

K944900 ↗

FDA Product Code

BWF

Device Class

Class II

Regulation

21 CFR Part 868.5690

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Dhd Metered Dose Inhaler (Mdi) Spacer (Modification)

  Class II

  FDA 510(k) K953206 Active Cleared 28 Aug 1995

• Dhd Metered Dose Inhaler (Mdi) Spacer

  Class II

  FDA 510(k) K913326 Active Cleared 7 Jan 1992

• Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral Actuator

  Class II

  FDA 510(k) K973532 Active Cleared 19 Mar 1998

• Duralife

  Class I

  FDA 510(k) K922537 Active Cleared 4 Dec 1992

• Ace Aerosol Enhancer, Hand Held Oral Inhalation Co

  Class II

  FDA 510(k) K926301 Active Cleared 21 Jul 1993

• Duralife(Tm)

  Class I

  FDA 510(k) K913726 Active Cleared 7 Feb 1992

See all devices from Dhd Diemolding Healthcare Div. →

• What is the Therapep device used for?

  Therapep is a therapeutic spirometer used in the field of anesthesiology as a Positive Expiratory Pressure (PEP) device to support lung expansion and airway clearance during respiratory therapy.

• How is the Therapep device supplied and what accessories are available?

  Therapep is supplied as a standalone device with optional accessories including a mouthpiece, pediatric mask, small mask, and large mask to accommodate different patient sizes and clinical needs.

• Is the Therapep device reusable or single-use?

  The device data does not specify whether Therapep is reusable or single-use; however, as a therapeutic spirometer with optional masks and mouthpiece, it is typically designed for multiple patient use with appropriate cleaning and disinfection between uses, following manufacturer guidelines.

• What regulatory pathway was used for Therapep's market authorization?

  Therapep received FDA 510(k) clearance K944900 on January 6, 1995, through a traditional review process, demonstrating substantial equivalence to a legally marketed predicate device.