Cleared Special

K140345 - THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

K140345 is an FDA 510(k) clearance for THE SHERLOCK 3CG TIP CONFIRMATION SYSTE..., manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 31-day FDA review.

K140345 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
31d
Days
Class 2
Risk

K140345 is an FDA 510(k) clearance for the THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS). 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 March 14, 2014 after a review of 31 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

FDA 510(k) Submission Details - K140345

510(k) Number K140345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2014
Decision Date March 14, 2014
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

LJS Device Classification - Class 2, Special Controls

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 213
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K140345.
Sherlock 3CG Tip Positioning System Stylet
K142267 · C.R. Bard, Inc. · Oct 2014
PICC Maximal Barrier Nursing Kit
K142616 · Navilyst Medical, Inc. · Oct 2014
PRO-PICC WITH VALVE TECHNOLOGY
K141633 · Medical Components, Inc. · Sep 2014
NMI PICC IV
K140266 · Navilyst Medical, Inc. · Mar 2014
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · Cook, Inc. · Dec 2013
NMI PICC III
K133264 · Navilyst Medical, Inc. · Nov 2013