Cleared Special

K112744 - SAPIENS TIP CONFIRMATION SYSTEM

K112744 is the FDA 510(k) clearance for SAPIENS TIP CONFIRMATION SYSTEM by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Special 510(k) pathway after a 29-day FDA review.

K112744 · C.R. Bard, Inc. · General Hospital
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Oct 2011
Decision
29d
Days
Class 2
Risk

K112744 is an FDA 510(k) clearance for the SAPIENS TIP CONFIRMATION SYSTEM. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K112744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2011
Decision Date October 20, 2011
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 128
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K112744.
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K100635 · Arrow Intl., Inc. · Aug 2010