Cleared Traditional

K922563 - LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)

K922563 is an FDA 510(k) clearance for LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELI..., manufactured by Raco Products Co.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K922563 · Raco Products Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
57d
Days
Class 2
Risk

K922563 is an FDA 510(k) clearance for the LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR). Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Raco Products Co. (Cleveland, US). The FDA issued a Cleared decision on July 28, 1992 after a review of 57 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 Raco Products Co. devices

FDA 510(k) Submission Details - K922563

510(k) Number K922563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date July 28, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
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 K922563.
MARQUETTE SERIES 360 DEFIBRILLATOR
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BATTERY PACK
K923864 · Portable Power Systems, Inc. · Oct 1992
MODEL #340 STEALTH-TRODE+LS
K923297 · Cardiotronics, Inc. · Sep 1992
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)
K922172 · Cardiotronics, Inc. · Jun 1992
MODEL # 830 ST ADULT STIMULATION PADS (STERILE)
K922173 · Cardiotronics, Inc. · Jun 1992
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE
K922227 · Cardiotronics, Inc. · Jun 1992