Cleared Special

K042501 - ETG-4000 OPTICAL TOPOGRAPHY SYSTEM

K042501 is an FDA 510(k) clearance for ETG-4000 OPTICAL TOPOGRAPHY SYSTEM, manufactured by Hitachi Medical Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 28-day FDA review.

K042501 · Hitachi Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
28d
Days
Class 2
Risk

K042501 is an FDA 510(k) clearance for the ETG-4000 OPTICAL TOPOGRAPHY SYSTEM. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Hitachi Medical Corp. (Twinsburg, US). The FDA issued a Cleared decision on October 12, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hitachi Medical Corp. devices

FDA 510(k) Submission Details - K042501

510(k) Number K042501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2004
Decision Date October 12, 2004
Days to Decision 28 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 626
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K042501.
PMP4 OXY PRO
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K042704 · Elekon Industries U.S.A., Inc. · Nov 2004
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
K042306 · Philips Medizin Systeme Boeblingen GmbH · Oct 2004
LNCS OXIMETRY SENSORS
K042346 · Masimo Corporation · Sep 2004
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
K041522 · Elekon Industries U.S.A., Inc. · Sep 2004
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
K041964 · Mediaid, Inc. · Sep 2004