Cleared Traditional

K961263 - MODEL 1200 ABMULATORY INFUSION PUMP

K961263 is an FDA 510(k) clearance for MODEL 1200 ABMULATORY INFUSION PUMP, manufactured by Patient Solutions, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K961263 · Patient Solutions, Inc. · General Hospital
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Aug 1996
Decision
143d
Days
Class 2
Risk

K961263 is an FDA 510(k) clearance for the MODEL 1200 ABMULATORY INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Patient Solutions, Inc. (San Diego, US). The FDA issued a Cleared decision on August 23, 1996 after a review of 143 days - within the typical 510(k) review window.

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 Patient Solutions, Inc. devices

FDA 510(k) Submission Details - K961263

510(k) Number K961263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received April 02, 1996
Decision Date August 23, 1996
Days to Decision 143 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 528
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K961263.
DISETRONIC D-MODEM
K961975 · Disetronic Medical Systems · Jan 1997
GEMINI PC-ITX
K960512 · Imed Corp. · Nov 1996
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
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
K960957 · Sims Deltec, Inc. · Jun 1996