Cleared Traditional

K092947 - TELESENTRY

K092947 is an FDA 510(k) clearance for TELESENTRY, manufactured by Scottcare Corporation. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K092947 · Scottcare Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
155d
Days
Class 2
Risk

K092947 is an FDA 510(k) clearance for the TELESENTRY, MODEL TS01. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Scottcare Corporation (Cleveland, US). The FDA issued a Cleared decision on February 26, 2010 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Scottcare Corporation devices

FDA 510(k) Submission Details - K092947

510(k) Number K092947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2009
Decision Date February 26, 2010
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 263
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K092947.
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INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
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INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
K083517 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jan 2009