Cleared Special

MODIFICATION TO: BODYGUARD INFUSION SYSTEM (K070718) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K070718 · Caesarea Medical Electronics , Ltd. · General Hospital
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Apr 2007
Decision
30d
Days
Class 2
Risk

K070718 is an FDA 510(k) clearance for the MODIFICATION TO: BODYGUARD 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 April 13, 2007 after a review of 30 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Caesarea Medical Electronics , Ltd. devices

Submission Details

510(k) Number K070718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2007
Decision Date April 13, 2007
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 847
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