Cleared Traditional

K061875 - MINISPIR

Also marketed or referenced as:
SPIROLAB III

K061875 is an FDA 510(k) clearance for MINISPIR, 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 161-day FDA review.

K061875 · 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
Dec 2006
Decision
161d
Days
Class 2
Risk

K061875 is an FDA 510(k) clearance for the MINISPIR. 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 December 11, 2006 after a review of 161 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 - K061875

510(k) Number K061875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date December 11, 2006
Days to Decision 161 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
21d slower than avg
Panel avg: 140d · This submission: 161d
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 K061875.
ASTRA 300
K061571 · Sdi Diagnostics, Inc. · Jan 2007
ASTRAGUARD PULMONARY FUNCTION FILTER
K062913 · Sdi Diagnostics, Inc. · Jan 2007
PULMOLIFE
K061283 · Micro Medical, Ltd. · Dec 2006
SPIROBANK II
K061712 · Mir Medical Intl. Research Srl · Dec 2006
SPIROLAB, SPIROLAB II
K052140 · Mir Medical Intl. Research Srl · Mar 2006
FLOWHANDY ZAN100 USB
K052176 · Zan Messgerate GmbH · Jan 2006