Cleared Abbreviated

K080704 - LOW FLUID ALARM

K080704 is an FDA 510(k) clearance for LOW FLUID ALARM, manufactured by Em-Tec GmbH. The device is a Class 2 General Hospital device with product code FLN cleared through the Abbreviated 510(k) pathway after a 36-day FDA review.

K080704 · Em-Tec GmbH · General Hospital
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Apr 2008
Decision
36d
Days
Class 2
Risk

K080704 is an FDA 510(k) clearance for the LOW FLUID ALARM. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Em-Tec GmbH (Finning, Bavaria, DE). The FDA issued a Cleared decision on April 17, 2008 after a review of 36 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080704

510(k) Number K080704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2008
Decision Date April 17, 2008
Days to Decision 36 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 25
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K080704.
DripAssist Plus
K172242 · Shift Labs, Inc. · May 2018
DripAssist
K150687 · Shift Labs · Oct 2015
FLUID LEVEL MONITOR
K133870 · Coleman Laboratories · Apr 2014
ISSYS DRUG FLOW MONITOR
K050783 · Integrated Sensing Systems, Inc. · Feb 2006
LEVELERT II FLUID LEVEL SENSOR
K060123 · Smith & Nephew, Inc. · Feb 2006
DRIP ALERT
K030136 · Drip Alert, Inc. · Apr 2003

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K080704 · LOW FLUID ALARM
Download PDF Em-Tec GmbH