Cleared Traditional

K871344 - PATHFINDER 3

K871344 is the FDA 510(k) clearance for PATHFINDER 3 by Reynolds Medical , Ltd.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K871344 · Reynolds Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
197d
Days
Class 2
Risk

K871344 is an FDA 510(k) clearance for the PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Reynolds Medical , Ltd. (Herts Sg14 1hz, GB). The FDA issued a Cleared decision on October 20, 1987 after a review of 197 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 Reynolds Medical , Ltd. devices

Submission Details

510(k) Number K871344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1987
Decision Date October 20, 1987
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 232
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K871344.
CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988
FUKUDA DENSHI MODEL FCP-231
K874768 · Fukuda Denshi USA, Inc. · Dec 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · Oxford Medilog, Inc. · Nov 1987
MODEL MR-45 AMBULATORY HOLTER MONITOR
K872497 · Oxford Medilog, Inc. · Oct 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · Nihon Kohden America, Inc. · Sep 1987
FUKUDA DENSHI MODEL FCP-15
K871025 · Fukuda Denshi USA, Inc. · Mar 1987