Cleared Traditional

K072634 - EMG TRITON -COMP

K072634 is an FDA 510(k) clearance for EMG TRITON -COMP, manufactured by Emg Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 428-day FDA review.

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

FDA 510(k) Submission Details - K072634

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
288d slower than avg
Panel avg: 140d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BTI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BTI Compressor, Air, Portable

All 31
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K072634.
MINIMATE COMPRESSOR
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K031686 · Medline Industries, Inc. · Jan 2004
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K023354 · Siemens Elema AB · Sep 2003
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K982789 · Drager, Inc. · Oct 1998
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997