Cleared Abbreviated

K061325 - BODYGAURD PAIN MANAGER INFUSION SYSTEM

K061325 is an FDA 510(k) clearance for BODYGAURD PAIN MANAGER INFUSION SYSTEM, manufactured by Caesarea Medical Electronics , Ltd.. The device is a Class 2 General Hospital device with product code FRN cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K061325 · Caesarea Medical Electronics , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
105d
Days
Class 2
Risk

K061325 is an FDA 510(k) clearance for the BODYGAURD PAIN MANAGER INFUSION 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 August 24, 2006 after a review of 105 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Caesarea Medical Electronics , Ltd. devices

FDA 510(k) Submission Details - K061325

510(k) Number K061325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2006
Decision Date August 24, 2006
Days to Decision 105 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

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 K061325.
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
K062592 · Smiths Medical MD, Inc. · Nov 2006
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K062699 · B.Braun Medical, Inc. · Oct 2006
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K062700 · B.Braun Medical, Inc. · Oct 2006
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K061128 · Medrad, Inc. · May 2006
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087
K060806 · Hospira, Inc. · Apr 2006
WILLCARE, MODEL GW-1020
K052594 · Icu Medical, Inc. · Feb 2006