Cleared Traditional

K031102 - MICROLAB SPIROMETER

K031102 is an FDA 510(k) clearance for MICROLAB SPIROMETER, manufactured by Micro Direct, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K031102 · Micro Direct, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
238d
Days
Class 2
Risk

K031102 is an FDA 510(k) clearance for the MICROLAB SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Micro Direct, Inc. (Lewiston, US). The FDA issued a Cleared decision on December 1, 2003 after a review of 238 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 - K031102

510(k) Number K031102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date December 01, 2003
Days to Decision 238 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
98d slower than avg
Panel avg: 140d · This submission: 238d
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 187
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K031102.
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
K033518 · Custom Plastic Products · Mar 2004
FLOSENSE II, MODEL 29-8040
K033939 · Sdi Diagnostics, Inc. · Jan 2004
SPIROTEL, MODEL 29-1020
K031643 · Sdi Diagnostics, Inc. · Dec 2003
GEM
K030917 · Collins Medical, Inc. · May 2003
IQTEQ SPIROMETER
K020102 · Iqteq Development · Mar 2003
GEM, MODEL 004110
K030464 · Collins Medical, Inc. · Mar 2003
K031102 · MICROLAB SPIROMETER
Download PDF FDA Summary Micro Direct, Inc.