Cleared Traditional

K931348 - BATTERY PACK #1005NC

K931348 is an FDA 510(k) clearance for BATTERY PACK #1005NC, manufactured by Portable Power Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K931348 · Portable Power Systems, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
337d
Days
Class 2
Risk

K931348 is an FDA 510(k) clearance for the BATTERY PACK #1005NC. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Castle Rock, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Portable Power Systems, Inc. devices

FDA 510(k) Submission Details - K931348

510(k) Number K931348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date February 17, 1994
Days to Decision 337 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 115d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 102
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K931348.
COOK ASPIRATION/IRRIGATION UNIT
K944818 · Cook Urological, Inc. · Nov 1994
R&D BATTERIES, PART NOS. 5243, 5104, AND 5481
K942033 · R & D Batteries, Inc. · Jun 1994
LIFE VAC
K940934 · Life Support Products, Inc. · May 1994
PM PUMP ASPIRATOR
K932494 · Precision Medical, Inc. · Oct 1993
INTELIJET SUCTION SUPPLY
K922176 · Smith & Nephew Dyonics, Inc. · Nov 1992
AUTOVAC
K921107 · Life Support Products, Inc. · Sep 1992