Cleared Traditional

K052140 - SPIROLAB, SPIROLAB II

K052140 is an FDA 510(k) clearance for SPIROLAB, manufactured by Mir Medical Intl. Research Srl. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K052140 · Mir Medical Intl. Research Srl · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
220d
Days
Class 2
Risk

K052140 is an FDA 510(k) clearance for the SPIROLAB, SPIROLAB II. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Mir Medical Intl. Research Srl (Roma, IT). The FDA issued a Cleared decision on March 16, 2006 after a review of 220 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 - K052140

510(k) Number K052140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2005
Decision Date March 16, 2006
Days to Decision 220 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
80d slower than avg
Panel avg: 140d · This submission: 220d
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 K052140.
PULMOLIFE
K061283 · Micro Medical, Ltd. · Dec 2006
MINISPIR
K061875 · Mir Medical Intl. Research Srl · Dec 2006
SPIROBANK II
K061712 · Mir Medical Intl. Research Srl · Dec 2006
FLOWHANDY ZAN100 USB
K052176 · Zan Messgerate GmbH · Jan 2006
KOKO LEGEND
K051572 · Pulmonary Data Services, Inc. · Nov 2005
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
K052158 · Welch Allyn, Inc. · Sep 2005