Cleared Traditional

SPIRODOC (K103530) - FDA 510(k) Clearance

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

K103530 · Medical International Research USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
355d
Days
Class 2
Risk

K103530 is an FDA 510(k) clearance for the SPIRODOC. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Medical International Research USA, Inc. (Waukesha, US). The FDA issued a Cleared decision on November 21, 2011 after a review of 355 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.

View all Medical International Research USA, Inc. devices

Submission Details

510(k) Number K103530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2010
Decision Date November 21, 2011
Days to Decision 355 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
215d slower than avg
Panel avg: 140d · This submission: 355d
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 K103530.
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K191013 · Welch Allyn, Inc. · Sep 2019
ComPAS2 (Computerized Pulmonary Analysis System)
K190568 · Morgan Scientific, Inc. · Jun 2019
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