Cleared Traditional

K953948 - SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO

K953948 is an FDA 510(k) clearance for SPIROVISION SV-III PC BASED SPIROMETER ..., manufactured by Futuremed America, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K953948 · Futuremed America, Inc. · Anesthesiology device
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Jun 1996
Decision
314d
Days
Class 2
Risk

K953948 is an FDA 510(k) clearance for the SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Futuremed America, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 25, 1996 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Futuremed America, Inc. devices

FDA 510(k) Submission Details - K953948

510(k) Number K953948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date June 25, 1996
Days to Decision 314 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 140d · This submission: 314d
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 70
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K953948.
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K944762 · Puritan Bennett Corp. · Dec 1994
L.A.P. II SPRIOMETRY SYSTEM
K932936 · Allied Healthcare Products, Inc. · Feb 1994
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988 · Sensor Medics Corp. · Oct 1993