Cleared Traditional

K141793 - PULMONE MINIBOXPFT 2.0

K141793 is an FDA 510(k) clearance for PULMONE MINIBOXPFT 2.0, manufactured by Pulmone Advanced Medical Devices, Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K141793 · Pulmone Advanced Medical Devices, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
247d
Days
Class 2
Risk

K141793 is an FDA 510(k) clearance for the PULMONE MINIBOXPFT 2.0. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Pulmone Advanced Medical Devices, Ltd. (Minneapolis, US). The FDA issued a Cleared decision on March 6, 2015 after a review of 247 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 - K141793

510(k) Number K141793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2014
Decision Date March 06, 2015
Days to Decision 247 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
107d slower than avg
Panel avg: 140d · This submission: 247d
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
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