Cleared Traditional

K072634 - EMG TRITON -COMP,MODEL NCA01-XXX SERIES (FDA 510(k) Clearance)

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

K072634 · Emg Technology Co., Ltd. · Anesthesiology device
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Nov 2008
Decision
428d
Days
Class 2
Risk

K072634 is an FDA 510(k) clearance for the EMG TRITON -COMP,MODEL NCA01-XXX SERIES. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Emg Technology Co., Ltd. (Shituen Chiu, Taichung, TW). The FDA issued a Cleared decision on November 19, 2008 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Emg Technology Co., Ltd. devices

Submission Details

510(k) Number K072634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2007
Decision Date November 19, 2008
Days to Decision 428 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
289d slower than avg
Panel avg: 139d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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.