Cleared Traditional

K840239 - VOFLEX

K840239 is an FDA 510(k) clearance for VOFLEX, manufactured by Dhd Medical Products Div. Diemolding Corp.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K840239 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device
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Mar 1984
Decision
45d
Days
Class 2
Risk

K840239 is an FDA 510(k) clearance for the VOFLEX. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Dhd Medical Products Div. Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 45 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dhd Medical Products Div. Diemolding Corp. devices

FDA 510(k) Submission Details - K840239

510(k) Number K840239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date March 05, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 140d · This submission: 45d
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 45
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K840239.
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334 · American Pharmaseal Div. Ahsc · Aug 1985
VITAPEP
K844963 · Vitalograph , Ltd. · Jun 1985
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369 · Electro-Catheter Corp. · Aug 1984
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
K840418 · Inspiron Corp. · Feb 1984
VOLUREX II
K833337 · Dhd Medical Products Div. Diemolding Corp. · Nov 1983
INSPIRATORY RESISTOR KIT
K831142 · Dhd Medical Products Div. Diemolding Corp. · Jun 1983