Cleared Traditional

K940467 - REMINGTON MEDICAL DISPOSABLE EXTENSION ...

K940467 is an FDA 510(k) clearance for REMINGTON MEDICAL DISPOSABLE EXTENSION ..., manufactured by Remington Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K940467 · Remington Medical, Inc. · Cardiovascular device
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Nov 1994
Decision
272d
Days
Class 2
Risk

K940467 is an FDA 510(k) clearance for the REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Remington Medical, Inc. (Atlanta, US). The FDA issued a Cleared decision on November 1, 1994 after a review of 272 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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 Remington Medical, Inc. devices

FDA 510(k) Submission Details - K940467

510(k) Number K940467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1994
Decision Date November 01, 1994
Days to Decision 272 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 125d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 29
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K940467.
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POWERCHARGER
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EXTERNAL DEMAND PACEMAKER
K923621 · Oscor Medical Corp. · May 1993
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991