Cleared Traditional

K031749 - BODYGUARD INFUSION SYSTEM

K031749 is an FDA 510(k) clearance for BODYGUARD INFUSION SYSTEM, 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 77-day FDA review.

K031749 · Caesarea Medical Electronics , Ltd. · General Hospital
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Aug 2003
Decision
77d
Days
Class 2
Risk

K031749 is an FDA 510(k) clearance for the 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 August 21, 2003 after a review of 77 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 - K031749

510(k) Number K031749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2003
Decision Date August 21, 2003
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K031749.
ABBOTT DATA PORT PC, MODEL 12181
K040114 · Abbott Laboratories · Jan 2004
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · Medrad, Inc. · Sep 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · Medtronic Minimed · Aug 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
K032147 · Alaris Medical Systems, Inc. · Jul 2003
MODIFICATION TO STRYKER PAINPUMP
K031249 · Stryker Instruments · Jul 2003
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · The Anspach Effort, Inc. · May 2003