Cleared Traditional

IQTEQ SPIROMETER (K020102) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020102 · Iqteq Development · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
434d
Days
Class 2
Risk

K020102 is an FDA 510(k) clearance for the IQTEQ SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Iqteq Development (Cape Town, Western Cape, ZA). The FDA issued a Cleared decision on March 21, 2003 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Iqteq Development devices

Submission Details

510(k) Number K020102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2002
Decision Date March 21, 2003
Days to Decision 434 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
294d slower than avg
Panel avg: 140d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K020102.
Pulmonx Chartis Tablet Console
K180011 · Pulmonx Corporation · Jul 2018
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K082478 · Welch Allyn, Inc. · Mar 2009
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
K052158 · Welch Allyn, Inc. · Sep 2005
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225 · Puritan Bennett Corp. · Dec 2002
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103 · Puritan Bennett Corp. · Sep 2002
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994