Cleared Traditional

K072634 - EMG TRITON -COMP,MODEL NCA01-XXX SERIES

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

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.

Regulatory Peers - BTI Compressor, Air, Portable

All 45
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K072634.
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