Cleared Abbreviated

K061256 - SMARTMONITOR 2PS (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K061256 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
90d
Days
Class 2
Risk

K061256 is an FDA 510(k) clearance for the SMARTMONITOR 2PS. Classified as Monitor, Apnea, Home Use (product code NPF), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on August 2, 2006 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Respironics, Inc. devices

Submission Details

510(k) Number K061256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2006
Decision Date August 02, 2006
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 139d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NPF Monitor, Apnea, Home Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
Definition Same As The Identification For Product Code Fls, Just Add Home Use
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.