Cleared Traditional

K062754 - GAS MODULE SE

K062754 is the FDA 510(k) clearance for GAS MODULE SE by Datascope Corp.. It is a Class 2 Anesthesiology device (product code BZK) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K062754 · Datascope Corp. · Anesthesiology device
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Nov 2006
Decision
49d
Days
Class 2
Risk

K062754 is an FDA 510(k) clearance for the GAS MODULE SE, MODEL 0998-00-0481-02. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Datascope Corp. (Mahwh, US). The FDA issued a Cleared decision on November 2, 2006 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 Datascope Corp. devices

Submission Details

510(k) Number K062754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2006
Decision Date November 02, 2006
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 14
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