Cleared Traditional

K060307 - 12 RL ALGORITHM (FDA 510(k) Clearance)

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

K060307 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
178d
Days
Class 2
Risk

K060307 is an FDA 510(k) clearance for the 12 RL ALGORITHM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on August 4, 2006 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K060307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2006
Decision Date August 04, 2006
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 337
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K060307.
The Circadia C300 System (C300)
K252676 · Circadia Health, Inc. · Feb 2026
Sleepiz One+ (Model 2.5)
K253388 · Sleepiz AG · Jan 2026
Sleepiz One+ (2.5)
K251364 · Sleepiz AG · Jul 2025
The Circadia C200 System
K234003 · Circadia Technologies, Ltd. · May 2024
Vios Monitoring System(TM) Model 2050
K232354 · Murata Vios, Inc. · Mar 2024
Neteera 130H-Plus Vital Sign Monitoring Sensor
K231733 · Neteera Technologies , Ltd. · Feb 2024