Cleared Traditional

K884832 - PERCUSSIONAIRE RESPIRATORS (MULTIPLE)

K884832 is an FDA 510(k) clearance for PERCUSSIONAIRE RESPIRATORS (MULTIPLE), 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 300-day FDA review.

K884832 · Percussionaire Corp. · Anesthesiology device
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Sep 1989
Decision
300d
Days
Class 2
Risk

K884832 is an FDA 510(k) clearance for the PERCUSSIONAIRE RESPIRATORS (MULTIPLE). 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 September 14, 1989 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 - K884832

510(k) Number K884832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date September 14, 1989
Days to Decision 300 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 140d · This submission: 300d
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 K884832.
TYPE 9291 INTERFACE RESPIRATOR
K896736 · S & W Medico Teknik · Feb 1990
8400ST VOLUME VENTILATOR
K894322 · Bird Products Corp. · Jan 1990
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989
NEWPORT VENTILATOR MODEL E150
K883809 · Newport Medical Instruments, Inc. · Jun 1989
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989