Cleared Special

K080954 - T34L SYRINGE DRIVER

K080954 is an FDA 510(k) clearance for T34L SYRINGE DRIVER, 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 43-day FDA review.

K080954 · Caesarea Medical Electronics , Ltd. · General Hospital
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May 2008
Decision
43d
Days
Class 2
Risk

K080954 is an FDA 510(k) clearance for the T34L SYRINGE DRIVER. 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 16, 2008 after a review of 43 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

FDA 510(k) Submission Details - K080954

510(k) Number K080954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date May 16, 2008
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 542
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K080954.
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K070125 · Baxter Healthcare Corp · Apr 2007