Cleared Traditional

K894997 - PRESTO DIAGNOSTIC SPIROMETER

K894997 is the FDA 510(k) clearance for PRESTO DIAGNOSTIC SPIROMETER by Tamarac Systems Corp.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K894997 · Tamarac Systems Corp. · Anesthesiology device
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Oct 1989
Decision
83d
Days
Class 2
Risk

K894997 is an FDA 510(k) clearance for the PRESTO DIAGNOSTIC SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Tamarac Systems Corp. (Denver, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 83 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 Tamarac Systems Corp. devices

Submission Details

510(k) Number K894997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date October 30, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K894997.
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
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PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985
SPIROMED 2
K851620 · Draeger Medical, Inc. · May 1985