Cleared Traditional

K123797 - NT1D VITAL SIGNS MONITOR

K123797 is an FDA 510(k) clearance for NT1D VITAL SIGNS MONITOR, manufactured by New Tech, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K123797 · New Tech, Inc. · Anesthesiology device
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Aug 2013
Decision
260d
Days
Class 2
Risk

K123797 is an FDA 510(k) clearance for the NT1D VITAL SIGNS MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by New Tech, Inc. (Shanghai, CN). The FDA issued a Cleared decision on August 27, 2013 after a review of 260 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 New Tech, Inc. devices

FDA 510(k) Submission Details - K123797

510(k) Number K123797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date August 27, 2013
Days to Decision 260 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
120d slower than avg
Panel avg: 140d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K123797.
PULSE OXIMETER
K131021 · Nonin Medical, Inc. · Sep 2013
IHEALTH FINGERTIP PULSE OXIMETER
K131111 · Andon Health Co, Ltd. · Sep 2013
VITAL SIGNS MONITOR
K131818 · Edan Instruments, Inc. · Aug 2013
FINGERTIP PULSE OXIMETER
K123871 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2013
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
K120984 · Masimo Corporation · Apr 2013
WRIST PULSE OXIMETER
K122046 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2013