Cleared Traditional

K925675 - BATTERY PACK #1015NC

K925675 is an FDA 510(k) clearance for BATTERY PACK #1015NC, manufactured by Portable Power Systems, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K925675 · Portable Power Systems, Inc. · General Hospital
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May 1993
Decision
197d
Days
Class 2
Risk

K925675 is an FDA 510(k) clearance for the BATTERY PACK #1015NC. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Parker, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 197 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - 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

FDA 510(k) Submission Details - K925675

510(k) Number K925675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date May 26, 1993
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
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 - FLL Continuous Measurement Thermometer

All 546
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K925675.
MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
K915633 · S & W Medico Teknik · Jun 1993
OMRON TYMPANIC THERMOMETER MC-500
K922344 · Omron Healthcare, Inc. · Jun 1993
BATTERY PACK #1014NC
K925674 · Portable Power Systems, Inc. · May 1993
ADAP-TEMP TEMPERATURE SENSOR ADAPTER
K921190 · Respiratory Support Products, Inc. · Mar 1993
MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
K920469 · Respiratory Support Products, Inc. · Sep 1992
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K912742 · Spacelabs, Inc. · Apr 1992