Cleared Traditional

K113096 - MICRO I

K113096 is an FDA 510(k) clearance for MICRO I, manufactured by Carefusion Germany 234 GmbH. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K113096 · Carefusion Germany 234 GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
177d
Days
Class 2
Risk

K113096 is an FDA 510(k) clearance for the MICRO I. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Carefusion Germany 234 GmbH (Hoechberg, DE). The FDA issued a Cleared decision on April 13, 2012 after a review of 177 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.

FDA 510(k) Submission Details - K113096

510(k) Number K113096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2011
Decision Date April 13, 2012
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
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 158
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K113096.
CCS-200 SPIROMETER
K123896 · Benson Medical Instruments Co. · Sep 2013
MINISPIR
K122384 · Mir Medical Intl. Research Srl · Oct 2012
ORBIT
K120880 · National Biomedical, LLC Dba Qrs Diagnostic · Apr 2012
SPIRODOC
K103530 · Medical International Research USA, Inc. · Nov 2011
CHARTIS CONSOLE
K111764 · Pulmonx, Inc. · Nov 2011
SPIRO PD
K103575 · Pmd Healthcare · Nov 2011