Cleared Traditional

DEFI 502 (K851485) - FDA 510(k) Clearance

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

K851485 · Robert Bosch Corp. · Cardiovascular device
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Aug 1985
Decision
136d
Days
Class 2
Risk

K851485 is an FDA 510(k) clearance for the DEFI 502. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Robert Bosch Corp. (St. James, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 136 days - within the typical 510(k) review window.

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 Robert Bosch Corp. devices

Submission Details

510(k) Number K851485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date August 29, 1985
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 165
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K851485.
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MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
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MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · Hewlett-Packard Co. · Aug 1989
MODEL 43130A DEFIBRILLATOR
K853439 · Hewlett-Packard Co. · Oct 1985