Cleared Traditional

K880672 - SENTINEL PULSE OXIMETER

K880672 is an FDA 510(k) clearance for SENTINEL PULSE OXIMETER, manufactured by Sentinel Monitoring Technologies, Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K880672 · Sentinel Monitoring Technologies, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
77d
Days
Class 2
Risk

K880672 is an FDA 510(k) clearance for the SENTINEL PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sentinel Monitoring Technologies, Ltd. (Indianapolis, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 77 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.

FDA 510(k) Submission Details - K880672

510(k) Number K880672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1988
Decision Date May 06, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 697
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K880672.
EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER
K881820 · Edentec Corp. · Jul 1988
SATLITE+/PB251+ PULSE OXIMETER
K881883 · Datex Division Instrumentarium Corp. · Jul 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · Hewlett-Packard Co. · May 1988
502-US PULSE OXIMETER
K875298 · Criticare Systems, Inc. · Mar 1988
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
K874442 · Critikon Company, LLC · Feb 1988
MODEL 8800 CARDIORESPIRATORY OXIMETER
K874947 · Nonin Medical, Inc. · Feb 1988
K880672 · SENTINEL PULSE OXIMETER
Download PDF Sentinel Monitoring T…