Cleared Traditional

K020004 - CLINDATALINK VERSION 1.0 FOR SPIROMETRY

K020004 is an FDA 510(k) clearance for CLINDATALINK VERSION 1.0 FOR SPIROMETRY, manufactured by Compleware Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K020004 · Compleware Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
203d
Days
Class 2
Risk

K020004 is an FDA 510(k) clearance for the CLINDATALINK VERSION 1.0 FOR SPIROMETRY. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Compleware Corp. (Iowa City, US). The FDA issued a Cleared decision on July 24, 2002 after a review of 203 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 - K020004

510(k) Number K020004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2002
Decision Date July 24, 2002
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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 227
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K020004.
KOKOMATE
K022276 · Ferraris Respiratory, Inc. · Oct 2002
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103 · Puritan Bennett Corp. · Sep 2002
PULMOLAB EX671 EXERCISE TESTING SYSTEM
K020280 · Morgan Medical , Ltd. · Sep 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123 · Engineered Medical Systems · Mar 2002
SPL-50 SPIROLYSER
K010761 · Fim Medical · Mar 2002
SPIROLAB II, MODEL 29
K013812 · Sdi Diagnostics, Inc. · Feb 2002
K020004 · CLINDATALINK VERSION 1.0 FOR SPIROMETRY
Download PDF FDA Summary Compleware Corp.