Cleared Traditional

K092813 - ASTRASONIC SPIROMETER, MODEL 29-8000

K092813 is an FDA 510(k) clearance for ASTRASONIC SPIROMETER, manufactured by Sdi Diagnostics, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K092813 · Sdi Diagnostics, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
305d
Days
Class 2
Risk

K092813 is an FDA 510(k) clearance for the ASTRASONIC SPIROMETER, MODEL 29-8000. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Sdi Diagnostics, Inc. (Easton, US). The FDA issued a Cleared decision on July 16, 2010 after a review of 305 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.

FDA 510(k) Submission Details - K092813

510(k) Number K092813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date July 16, 2010
Days to Decision 305 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
165d slower than avg
Panel avg: 140d · This submission: 305d
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 K092813.
MICRO DIARY SPIROMETER
K100928 · Viasys Respiratory Care, Inc. · Mar 2011
MASTERSCREEN IOS
K101873 · Carefusion Germany 234 GmbH · Feb 2011
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
K100687 · Vitalograph (Ireland) , Ltd. · Oct 2010
SPIROPALM
K093174 · Cosmed Srl · Feb 2010
ASTHMA MONITOR AM3
K092890 · Carefusion Germany 234 GmbH · Jan 2010
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
K090646 · Chest M.I., Inc. · Jul 2009