Cleared Traditional

K071672 - SENTEC DIGITAL MONITORING SYSTEM

K071672 is an FDA 510(k) clearance for SENTEC DIGITAL MONITORING SYSTEM, manufactured by Sentec AG. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K071672 · Sentec AG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
85d
Days
Class 2
Risk

K071672 is an FDA 510(k) clearance for the SENTEC DIGITAL MONITORING SYSTEM. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sentec AG (Egale, US). The FDA issued a Cleared decision on September 12, 2007 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sentec AG devices

FDA 510(k) Submission Details - K071672

510(k) Number K071672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2007
Decision Date September 12, 2007
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 454
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K071672.
FINGERTIP PULSE OXIMETER, MODEL MD300I
K072825 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2008
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
FINGERTIP PULSE OXIMETER MD300C
K070371 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · Nonin Medical, Inc. · Jul 2007