Cleared Traditional

K903657 - MODEL 610 MODIFIED

K903657 is an FDA 510(k) clearance for MODEL 610 MODIFIED, manufactured by First Medical Devices Corp.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K903657 · First Medical Devices Corp. · Cardiovascular device
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Sep 1990
Decision
26d
Days
Class 2
Risk

K903657 is an FDA 510(k) clearance for the MODEL 610 MODIFIED. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by First Medical Devices Corp. (Kirkland, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 26 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all First Medical Devices Corp. devices

FDA 510(k) Submission Details - K903657

510(k) Number K903657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1990
Decision Date September 04, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
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 K903657.
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
K905510 · Physio-Control Corp. · Dec 1990
MODEL #210 STEALTH DEFIB PADS
K904462 · Cardiotronics, Inc. · Dec 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478 · Physio-Control Corp. · Oct 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · Marquette Electronics, Inc. · Jul 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · Physio-Control Corp. · Feb 1990
DEFIB K-PADS
K895662 · Katecho, Inc. · Jan 1990