Cleared Traditional

K062149 - SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES

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

K062149 is an FDA 510(k) clearance for SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES, manufactured by International Business Strategies. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K062149 · International Business Strategies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K062149

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.

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 K062149.
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · Nonin Medical, Inc. · Jul 2007
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K071024 · Masimo Corporation · Jun 2007
DURAMAX REUSABLE OXIMETRY SENSOR
K070408 · Nellcor Puritan Bennett, Inc. · May 2007
LIFESENSE, MODEL LS1-9R
K063752 · Nonin Medical, Inc. · May 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