Cleared Special

K102757 - LIFENET SYSTEM (FDA 510(k) Clearance)

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

K102757 · Physio-Control, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
43d
Days
Class 2
Risk

K102757 is an FDA 510(k) clearance for the LIFENET SYSTEM. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on November 5, 2010 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Physio-Control, Inc. devices

Submission Details

510(k) Number K102757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2010
Decision Date November 05, 2010
Days to Decision 43 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 115
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K102757.
TigerConnect Alarm Management
K243270 · Tigerconnect · Sep 2025
BeneVision Central Monitoring System
K242728 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2025
Central Station
K242750 · Nihon Kohden Digital Health Solutions, LLC · Jun 2025
ANNE View, Central Hub
K242842 · Sibel Health, Inc. · Jan 2025
Hinscope
K241397 · Hinlab Sas · Nov 2024
Infinity Gateway Suite
K233834 · Draeger Medical Systems, Inc. · Jul 2024