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Therapep

by Dhd Healthcare Corp.

510(k) K983467

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983467 Date2 Apr 1999ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BWF
Device Class
Class II
Regulation
21 CFR Part 868.5690
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Therapep is a therapeutic spirometer, incentive type, classified as a Class 2 medical device under product code BWF. It is indicated for use in anesthesiology and was determined to be substantially equivalent through the traditional 510(k) pathway.

The device was manufactured by Dhd Healthcare Corp. and received FDA 510(k) clearance under K983467 on April 2, 1999. It is supplied as a device with optional accessories including mouthpiece, pediatric mask, small mask, and large mask, and is intended for use in clinical settings under professional supervision.

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