Cleared Special

K070235 - BODYGUARD PAIN MANAGER INFUSION SYSTEM

K070235 is an FDA 510(k) clearance for BODYGUARD 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 Special 510(k) pathway after a 113-day FDA review.

K070235 · Caesarea Medical Electronics , Ltd. · General Hospital
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May 2007
Decision
113d
Days
Class 2
Risk

K070235 is an FDA 510(k) clearance for the BODYGUARD 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 May 18, 2007 after a review of 113 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070235

510(k) Number K070235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2007
Decision Date May 18, 2007
Days to Decision 113 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

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 727
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K070235.
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K070235 · BODYGUARD PAIN MANAGER INFUSION SYSTEM
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