Cleared Traditional

K060616 - NPOSES (NOCTURNAL PULSE OXIMETRY STUDY ...

K060616 is an FDA 510(k) clearance for NPOSES (NOCTURNAL PULSE OXIMETRY STUDY ..., manufactured by PHD Medical. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K060616 · PHD Medical · Anesthesiology device
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Jun 2006
Decision
113d
Days
Class 2
Risk

K060616 is an FDA 510(k) clearance for the NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by PHD Medical (Dundas, CA). The FDA issued a Cleared decision on June 29, 2006 after a review of 113 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.

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FDA 510(k) Submission Details - K060616

510(k) Number K060616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2006
Decision Date June 29, 2006
Days to Decision 113 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
27d faster than avg
Panel avg: 140d · This submission: 113d
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 K060616.
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INFINITY MASIMO SET SP02 POD
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K060143 · Masimo Corporation · Jun 2006
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
K053381 · Welch Allyn, Inc. · Jun 2006
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
K061112 · Conmed Corporation · May 2006