Cleared Traditional

K013121 - MT ALERT INFUSION MONITOR

K013121 is an FDA 510(k) clearance for MT ALERT INFUSION MONITOR, manufactured by Sierra Biosearch, Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K013121 · Sierra Biosearch, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
27d
Days
Class 2
Risk

K013121 is an FDA 510(k) clearance for the MT ALERT INFUSION MONITOR. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Sierra Biosearch, Inc. (Bishop, US). The FDA issued a Cleared decision on October 15, 2001 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sierra Biosearch, Inc. devices

FDA 510(k) Submission Details - K013121

510(k) Number K013121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2001
Decision Date October 15, 2001
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 19
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K013121.
FLUID LEVEL MONITOR
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FLUID CENTURION (4-100-00)
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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