Cleared Traditional

SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES (K062149) - FDA 510(k) Clearance

Also marketed or referenced as:
SP02 SENSOR FC, FP AND Y SERIES

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062149 · International Business Strategies · Anesthesiology device
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May 2007
Decision
308d
Days
Class 2
Risk

K062149 is an FDA 510(k) clearance for the SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by International Business Strategies (Mount Pleasant, US). The FDA issued a Cleared decision on May 31, 2007 after a review of 308 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 International Business Strategies devices

Submission Details

510(k) Number K062149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2006
Decision Date May 31, 2007
Days to Decision 308 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
168d slower than avg
Panel avg: 140d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 189
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K062149.
N-600X WITH SPD, OXIMAX N-600X
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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
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
K063783 · Philips Medical Systems, Inc. · Apr 2007
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
K062605 · Philips Medical Systems · Nov 2006
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
K062455 · Philips Medical Systems · Nov 2006