Cleared Traditional

K905065 - DEFIBRILLATOR LEAD ADAPTER

K905065 is an FDA 510(k) clearance for DEFIBRILLATOR LEAD ADAPTER, manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K905065 · Spacelabs, Inc. · Cardiovascular device
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Apr 1991
Decision
156d
Days
Class 2
Risk

K905065 is an FDA 510(k) clearance for the DEFIBRILLATOR LEAD ADAPTER. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K905065

510(k) Number K905065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date April 12, 1991
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 86
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K905065.
K-FREE
K912587 · Katecho, Inc. · Jul 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144 · Physio-Control Corp. · Jul 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · Hewlett-Packard Co. · May 1991
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR
K902288 · Physio-Control Corp. · Feb 1991
MODEL #250 DEFIB CABLE
K904466 · Cardiotronics, Inc. · Jan 1991
SERIES 1500 RESPONDER
K902782 · Marquette Electronics, Inc. · Jan 1991