Cleared Traditional

K924413 - FLOWSCAN

K924413 is the FDA 510(k) clearance for FLOWSCAN by Electrocaine Medical System. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K924413 · Electrocaine Medical System · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
248d
Days
Class 2
Risk

K924413 is an FDA 510(k) clearance for the FLOWSCAN. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Electrocaine Medical System (Lancaster, US). The FDA issued a Cleared decision on May 6, 1993 after a review of 248 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Electrocaine Medical System devices

Submission Details

510(k) Number K924413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date May 06, 1993
Days to Decision 248 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 140d · This submission: 248d
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 K924413.
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K852092 · Puritan Bennett Corp. · Jul 1985