Cleared Traditional

K160253 - Vitalograph Model 6300 micro

K160253 is an FDA 510(k) clearance for Vitalograph Model 6300 micro, 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 207-day FDA review.

K160253 · Vitalograph (Ireland) , Ltd. · Anesthesiology device
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Aug 2016
Decision
207d
Days
Class 2
Risk

K160253 is an FDA 510(k) clearance for the Vitalograph Model 6300 micro. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph (Ireland) , Ltd. (Ennis, IE). The FDA issued a Cleared decision on August 26, 2016 after a review of 207 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 - K160253

510(k) Number K160253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date August 26, 2016
Days to Decision 207 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
67d slower than avg
Panel avg: 140d · This submission: 207d
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 K160253.
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K142812 · Vitalograph (Ireland) , Ltd. · Jun 2015