Cleared Special

K060123 - LEVELERT II FLUID LEVEL SENSOR

K060123 is an FDA 510(k) clearance for LEVELERT II FLUID LEVEL SENSOR, manufactured by Smith & Nephew, Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Special 510(k) pathway after a 27-day FDA review.

K060123 · Smith & Nephew, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
27d
Days
Class 2
Risk

K060123 is an FDA 510(k) clearance for the LEVELERT II FLUID LEVEL SENSOR. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on February 14, 2006 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - 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.

FDA 510(k) Submission Details - K060123

510(k) Number K060123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2006
Decision Date February 14, 2006
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

FLN Device Classification - Class 2, Special Controls

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
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 - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 38
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K060123.
FLUID LEVEL MONITOR
K133870 · Coleman Laboratories · Apr 2014
LOW FLUID ALARM
K080704 · Em-Tec GmbH · Apr 2008
ISSYS DRUG FLOW MONITOR
K050783 · Integrated Sensing Systems, Inc. · Feb 2006
DRIP ALERT
K030136 · Drip Alert, Inc. · Apr 2003
STRYKER L3 HYDROLERT
K022248 · Stryker Endoscopy · Aug 2002
MT ALERT INFUSION MONITOR
K013121 · Sierra Biosearch, Inc. · Oct 2001
K060123 · LEVELERT II FLUID LEVEL SENSOR
Download PDF FDA Summary Smith & Nephew, Inc.