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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 158
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