Cleared Traditional

K072722 - MEDDORNA WIRELESS PRN SPIROMETER 100

K072722 is an FDA 510(k) clearance for MEDDORNA WIRELESS PRN SPIROMETER 100, manufactured by Meddorna, LLC. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K072722 · Meddorna, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
211d
Days
Class 2
Risk

K072722 is an FDA 510(k) clearance for the MEDDORNA WIRELESS PRN SPIROMETER 100. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Meddorna, LLC (Houston, US). The FDA issued a Cleared decision on April 24, 2008 after a review of 211 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.

View all Meddorna, LLC devices

FDA 510(k) Submission Details - K072722

510(k) Number K072722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2007
Decision Date April 24, 2008
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 140d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 56
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