Cleared Traditional

K925449 - REPLACEMENT RECHARGEABLE BATTERY PACK'S

K925449 is the FDA 510(k) clearance for REPLACEMENT RECHARGEABLE BATTERY PACK'S by Portable Power Systems, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K925449 · Portable Power Systems, Inc. · General Hospital
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Apr 1993
Decision
183d
Days
Class 2
Risk

K925449 is an FDA 510(k) clearance for the REPLACEMENT RECHARGEABLE BATTERY PACK'S. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Parker, US). The FDA issued a Cleared decision on April 29, 1993 after a review of 183 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Portable Power Systems, Inc. devices

Submission Details

510(k) Number K925449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date April 29, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 129d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 444
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K925449.
MODEL 480CI INFUSION PUMP, MODIFICATION
K924870 · 3M Health Care, Ltd. · Jun 1993
MODEL 885 INFUSION PUMP, MODIFICATION
K924872 · 3M Health Care, Ltd. · Jun 1993
SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS
K923875 · I-Flow Corp. · May 1993
AVI MODEL 3100 INFUSION PUMP
K923068 · 3M Health Care, Ltd. · Apr 1993
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · Abbott Laboratories · Apr 1993
IVAC SYRINGE PUMP - 740 SERIES
K923981 · Y · Jan 1993