Cleared Traditional

NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 (K060616) - FDA 510(k) Clearance

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

K060616 · PHD Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all PHD Medical devices

Submission Details

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.

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 243
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K060616.
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
K062455 · Philips Medical Systems · Nov 2006
PULSE OXIMETER, MODEL PM-50
K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2006
MASIMO SET RADICAL 7 PULSE CO-OXIMETER
K061204 · Masimo Corporation · Jul 2006
LNCS AND SPO2.COM SENSORS
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