Cleared Traditional

K910452 - RESPI-PAK RT-PAK (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910452 · Cns, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
65d faster than avg
Panel avg: 139d · This submission: 74d
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 227
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K910452.
MESI mTABLET SPIRO
K251777 · Mesi D.O.O. · Mar 2026
TD-7301 Spirometer (TD-7301)
K241843 · Gostar Co., Ltd. · Nov 2024
Air Next (NVD-02)
K231416 · Nuvoair AB · Jan 2024
Spirobank Oxi
K230501 · Mir Medical International Research USA · Dec 2023
EasyOne Sky Spirometer
K230178 · Ndd Medizintechnik AG · Oct 2023
Alveoair Digital Spirometer
K222525 · Roundworks Technologies Private Limited · Aug 2023