Cleared Traditional

K960957 - EXTERNAL POWER SOURCE (EPS) SYSTEM

K960957 is the FDA 510(k) clearance for EXTERNAL POWER SOURCE (EPS) SYSTEM by Sims Deltec, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K960957 · Sims Deltec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
85d
Days
Class 2
Risk

K960957 is an FDA 510(k) clearance for the EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 4, 1996 after a review of 85 days - a notably fast clearance 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: 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 Sims Deltec, Inc. devices

Submission Details

510(k) Number K960957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date June 04, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 447
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K960957.
CADD-PRIZM MODEL 6100 PUMP
K960826 · Sims Deltec, Inc. · Aug 1996
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
K955231 · Medex, Inc. · Jul 1996
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
K961703 · Baxter Healthcare Corp · Jul 1996
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
K955180 · Sims Deltec, Inc. · May 1996
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
K953896 · Imed Corp. · Mar 1996
ABBOTT XL3M INFUSION PUMP
K952799 · Abbott Laboratories · Jan 1996