Cleared Traditional

K101568 - MODEL SB100II FINGER PULSE OXIMETER

K101568 is an FDA 510(k) clearance for MODEL SB100II FINGER PULSE OXIMETER, manufactured by Atlantean. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K101568 · Atlantean · Anesthesiology device
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Sep 2010
Decision
110d
Days
Class 2
Risk

K101568 is an FDA 510(k) clearance for the MODEL SB100II FINGER PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Atlantean (Bonita Springs, US). The FDA issued a Cleared decision on September 20, 2010 after a review of 110 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Atlantean devices

FDA 510(k) Submission Details - K101568

510(k) Number K101568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2010
Decision Date September 20, 2010
Days to Decision 110 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
30d faster than avg
Panel avg: 140d · This submission: 110d
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 K101568.
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K101600 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2010
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K100428 · Masimo Corporation · Jul 2010