Cleared Traditional

K130322 - SPM-300 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130322 · Bionet Co., Ltd. · Anesthesiology device
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Nov 2013
Decision
280d
Days
Class 2
Risk

K130322 is an FDA 510(k) clearance for the SPM-300. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Bionet Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on November 15, 2013 after a review of 280 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 Bionet Co., Ltd. devices

Submission Details

510(k) Number K130322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2013
Decision Date November 15, 2013
Days to Decision 280 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 139d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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