Cleared Traditional

K896903 - FIRST MEDIC MODEL 510

K896903 is an FDA 510(k) clearance for FIRST MEDIC MODEL 510, 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 384-day FDA review.

K896903 · Spacelabs, Inc. · Cardiovascular device
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Dec 1990
Decision
384d
Days
Class 2
Risk

K896903 is an FDA 510(k) clearance for the FIRST MEDIC MODEL 510. 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 December 27, 1990 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K896903

510(k) Number K896903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date December 27, 1990
Days to Decision 384 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
259d slower than avg
Panel avg: 125d · This submission: 384d
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 K896903.
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
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