Cleared Traditional

K864276 - PERSONAL INFUSION PUMP

K864276 is an FDA 510(k) clearance for PERSONAL INFUSION PUMP, manufactured by Bionica, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K864276 · Bionica, Inc. · General Hospital
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Mar 1987
Decision
139d
Days
Class 2
Risk

K864276 is an FDA 510(k) clearance for the PERSONAL INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Bionica, Inc. (Nsw 2120 Australia, AU). The FDA issued a Cleared decision on March 17, 1987 after a review of 139 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 Bionica, Inc. devices

FDA 510(k) Submission Details - K864276

510(k) Number K864276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date March 17, 1987
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
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 616
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K864276.
IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP
K870992 · Imed Corp. · Jun 1987
AMBULATORY INFUSION PUMP DRUG RESERVOIR
K870524 · Med Fusion Systems, Inc. · May 1987
HOMEPRO II VOLUMETRIC INFUSION PUMP
K870444 · American Edwards Laboratories · Apr 1987
MEDTRAC VP VOLUMETRIC INFUSION PUMP
K864997 · American Edwards Laboratories · Feb 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580
K864809 · Y · Feb 1987
ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
K865058 · Abbott Laboratories · Feb 1987