Cleared Traditional

K905235 - VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS

K905235 is an FDA 510(k) clearance for VDR SINUSOIDAL PERCUSIONATOR FAMILY/REL..., manufactured by Percussionaire Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K905235 · Percussionaire Corp. · Anesthesiology device
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May 1991
Decision
177d
Days
Class 2
Risk

K905235 is an FDA 510(k) clearance for the VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Percussionaire Corp. (Sandpoint, US). The FDA issued a Cleared decision on May 3, 1991 after a review of 177 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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.

View all Percussionaire Corp. devices

FDA 510(k) Submission Details - K905235

510(k) Number K905235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date May 03, 1991
Days to Decision 177 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 140d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 409
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K905235.
VENTILATOR STAND
K914485 · Bird Products Corp. · Oct 1991
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991
BABYLOG 8000 INFANT VENTILATOR
K903089 · Drager, Inc. · Jun 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K902405 · Mallinckrodt Medical · Mar 1991
ADULT STAR, MODIFICATION
K905272 · Infrasonics Corp. · Jan 1991