Cleared Traditional

K910811 - SENSOR SHIELD

K910811 is an FDA 510(k) clearance for SENSOR SHIELD, manufactured by Medical Taping Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 666-day FDA review.

K910811 · Medical Taping Systems, Inc. · Anesthesiology device
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Dec 1992
Decision
666d
Days
Class 2
Risk

K910811 is an FDA 510(k) clearance for the SENSOR SHIELD. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Medical Taping Systems, Inc. (Glenmoore, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 666 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

View all Medical Taping Systems, Inc. devices

FDA 510(k) Submission Details - K910811

510(k) Number K910811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1991
Decision Date December 23, 1992
Days to Decision 666 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
526d slower than avg
Panel avg: 140d · This submission: 666d
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 681
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K910811.
OXYSHUTTLE II ,MODIFICATION
K925542 · Sensor Medics Corp. · Feb 1993
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
BIOCHEM MODEL 3301 NEWOX1 OXIMETER
K920082 · Biochem International, Inc. · Jan 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
K920379 · Novametrix Medical Systems, Inc. · Jul 1992
SENSORMEDICS OXYSHUTTLE II(TM)
K913790 · Sensor Medics Corp. · Feb 1992