Cleared Traditional

K890522 - PURITAN BENNETT PB900A DIAGNOSTIC SPIRO...

K890522 is an FDA 510(k) clearance for PURITAN BENNETT PB900A DIAGNOSTIC SPIRO..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K890522 · Puritan Bennett Corp. · Anesthesiology device
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Apr 1989
Decision
78d
Days
Class 2
Risk

K890522 is an FDA 510(k) clearance for the PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K890522

510(k) Number K890522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1989
Decision Date April 21, 1989
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 49
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K890522.
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K895253 · Welch Allyn, Inc. · Nov 1989
SALTER VOLUCHEK 6600
K863656 · Salter Labs · Oct 1986
SCREENMATE
K853409 · Erich Jaeger, Inc. · Feb 1986
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K854403 · Gould, Inc. · Jan 1986