Cleared Traditional

K944900 - THERAPEP

K944900 is an FDA 510(k) clearance for THERAPEP, manufactured by Dhd Diemolding Healthcare Div.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K944900 · Dhd Diemolding Healthcare Div. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
94d
Days
Class 2
Risk

K944900 is an FDA 510(k) clearance for the THERAPEP. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Dhd Diemolding Healthcare Div. (Canastota, US). The FDA issued a Cleared decision on January 6, 1995 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K944900

510(k) Number K944900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1994
Decision Date January 06, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 140d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 86
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K944900.
THE BREATHER
K944412 · Pal Medical, Inc. · Apr 1995
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
K944344 · Lung Technologies, Inc. · Feb 1995
EXPIRATORY BREATHING EXERCISER
K945118 · Dhd Diemolding Healthcare Div. · Jan 1995
MERCURY EXPIRATORY RESISTANCE EXERCISER
K942919 · Mercury Ent., Inc. D/B/A Mercury Medical · Sep 1994
THRESHOLD 2X INSPIRATORY MUSCLE TRAINER
K912943 · Health Products, Inc. · Jan 1992
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · Monaghan Medical Corp. · Mar 1991
K944900 · THERAPEP
Download PDF FDA Summary Dhd Diemolding Health…