Cleared Traditional

K910452 - RESPI-PAK RT-PAK

K910452 is an FDA 510(k) clearance for RESPI-PAK RT-PAK, manufactured by Cns, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K910452 · Cns, Inc. · Anesthesiology device
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Apr 1991
Decision
74d
Days
Class 2
Risk

K910452 is an FDA 510(k) clearance for the RESPI-PAK RT-PAK. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Cns, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on April 16, 1991 after a review of 74 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 Cns, Inc. devices

FDA 510(k) Submission Details - K910452

510(k) Number K910452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1991
Decision Date April 16, 1991
Days to Decision 74 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 140d · This submission: 74d
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 130
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K910452.
VITALOGRAPH SPIROTRAC III
K912412 · Vitalograph , Ltd. · Oct 1991
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K904625 · Synectics-Dantec · Aug 1991
SPIROSIFT 500A
K904200 · Fukuda Denshi USA, Inc. · May 1991
SPIRO ANALYZER MODEL ST 250
K901308 · Futuremed Div. of Future Impex Corp. · Jul 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · Fukuda Denshi USA, Inc. · Apr 1990
SPIROSCAN 4000
K896924 · Brentwood Instruments, Inc. · Mar 1990