Cleared Traditional

K934015 - RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB

K934015 is an FDA 510(k) clearance for RECHARGE REPLACE BATTERY PK SPACELABS 4..., manufactured by Portable Power Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K934015 · Portable Power Systems, Inc. · Cardiovascular device
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Feb 1994
Decision
184d
Days
Class 2
Risk

K934015 is an FDA 510(k) clearance for the RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Parker, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 184 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 Portable Power Systems, Inc. devices

FDA 510(k) Submission Details - K934015

510(k) Number K934015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date February 17, 1994
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 125d · This submission: 184d
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 114
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K934015.
DPD DEFIBRILLATOR
K952085 · Medical Research Laboratories, Inc. · Jun 1995
PEDIATRIC DEFIB K-PADS
K935083 · Katecho, Inc. · Jul 1994
VITAL-COMBO(R)
K922315 · Physio-Control Corp. · Mar 1994
BATTERY PACK# S1024NC
K934508 · Portable Power Systems, Inc. · Feb 1994
BATTERY PACK #1012NC
K931266 · Portable Power Systems, Inc. · Feb 1994
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674 · Physio-Control Corp. · Dec 1993