Cleared Traditional

K100687 - VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120

K100687 is an FDA 510(k) clearance for VITALOGRAPH HAND HELD SPIROMETER, manufactured by Vitalograph (Ireland) , Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K100687 · Vitalograph (Ireland) , Ltd. · Anesthesiology device
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Oct 2010
Decision
220d
Days
Class 2
Risk

K100687 is an FDA 510(k) clearance for the VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph (Ireland) , Ltd. (Ennis, Co. Clare, IE). The FDA issued a Cleared decision on October 16, 2010 after a review of 220 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 Vitalograph (Ireland) , Ltd. devices

FDA 510(k) Submission Details - K100687

510(k) Number K100687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2010
Decision Date October 16, 2010
Days to Decision 220 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
80d slower than avg
Panel avg: 140d · This submission: 220d
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 147
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K100687.
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