Cleared Traditional

K060479 - MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM

K060479 is an FDA 510(k) clearance for MODIFICATION TO BODYGUARD INFUSION PUMP..., manufactured by Caesarea Medical Electronics , Ltd.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K060479 · Caesarea Medical Electronics , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
78d
Days
Class 2
Risk

K060479 is an FDA 510(k) clearance for the MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Caesarea Medical Electronics , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on May 12, 2006 after a review of 78 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 Caesarea Medical Electronics , Ltd. devices

FDA 510(k) Submission Details - K060479

510(k) Number K060479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2006
Decision Date May 12, 2006
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 542
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K060479.
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HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087
K060806 · Hospira, Inc. · Apr 2006
WILLCARE, MODEL GW-1020
K052594 · Icu Medical, Inc. · Feb 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006