Cleared Traditional

K133870 - FLUID LEVEL MONITOR

K133870 is an FDA 510(k) clearance for FLUID LEVEL MONITOR, manufactured by Coleman Laboratories. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K133870 · Coleman Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
125d
Days
Class 2
Risk

K133870 is an FDA 510(k) clearance for the FLUID LEVEL MONITOR. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Coleman Laboratories (King Of Prussia, US). The FDA issued a Cleared decision on April 24, 2014 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Coleman Laboratories devices

FDA 510(k) Submission Details - K133870

510(k) Number K133870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date April 24, 2014
Days to Decision 125 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 129d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 17
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K133870.
DripAssist Plus
K172242 · Shift Labs, Inc. · May 2018
LEVELERT II FLUID LEVEL SENSOR
K060123 · Smith & Nephew, Inc. · Feb 2006
STRYKER L3 HYDROLERT
K022248 · Stryker Endoscopy · Aug 2002
FLUID CENTURION (4-100-00)
K973025 · Northgate Technologies, Inc. · Nov 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K972084 · Alexander Mfg. Co. · Jul 1997
SMITH & NEPHEW DYONICS LEVELERT SYSTEM
K903193 · Smith & Nephew Dyonics, Inc. · Aug 1990