Cleared Traditional

K891122 - DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.

K891122 is an FDA 510(k) clearance for DISP. ACCESSORY TO EXTERNAL TRANS. CARD..., manufactured by Big Valley Medical. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K891122 · Big Valley Medical · Cardiovascular device
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Sep 1989
Decision
195d
Days
Class 2
Risk

K891122 is an FDA 510(k) clearance for the DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Big Valley Medical (Orangevale, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 195 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 Big Valley Medical devices

FDA 510(k) Submission Details - K891122

510(k) Number K891122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date September 13, 1989
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
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 117
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K891122.
DEFIB K-PADS
K895662 · Katecho, Inc. · Jan 1990
MARQUETTE 1200 DEFIBRILLATION PADS
K895651 · Marquette Electronics, Inc. · Dec 1989
COORDINATOR
K895113 · Cardiotronics, Inc. · Oct 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · Hewlett-Packard Co. · Aug 1989
LIFEPAK 10 DEFIBRILLATOR/MONITOR
K890079 · Physio-Control Corp. · Feb 1989
LIFEPAK 50 MONITOR/DEFIBRILLATOR
K883617 · Physio-Control Corp. · Dec 1988