Cleared Special

K061240 - SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES

K061240 is an FDA 510(k) clearance for SHERLOCK TIP LOCATION SYSTEM (TLS) DETE..., manufactured by Lucent Medical Systems. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 30-day FDA review.

K061240 · Lucent Medical Systems · General Hospital
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Jun 2006
Decision
30d
Days
Class 2
Risk

K061240 is an FDA 510(k) clearance for the SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Lucent Medical Systems (Kirkland, US). The FDA issued a Cleared decision on June 2, 2006 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 880.5970 - 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 Lucent Medical Systems devices

FDA 510(k) Submission Details - K061240

510(k) Number K061240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2006
Decision Date June 02, 2006
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
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.

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 231
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K061240.
ARROW PRESSURE INJECTABLE PICC
K061289 · Arrow International, Inc. · Aug 2006
POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER
K061179 · C.R. Bard, Inc. · Aug 2006
1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50
K061986 · Medcomp · Aug 2006
ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT
K060887 · AngioDynamics, Inc. · Apr 2006
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
K053345 · Medcomp · Mar 2006
POWERPICC
K053501 · Bard Access Systems, Inc. · Jan 2006