Cleared Traditional

K121198 - BW685

K121198 is an FDA 510(k) clearance for BW685, manufactured by Biegler GmbH. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K121198 · Biegler GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
84d
Days
Class 2
Risk

K121198 is an FDA 510(k) clearance for the BW685, BW685S. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Biegler GmbH (Bonita Springs, US). The FDA issued a Cleared decision on July 12, 2012 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Biegler GmbH devices

FDA 510(k) Submission Details - K121198

510(k) Number K121198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date July 12, 2012
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGZ Device Classification - Class 2, Special Controls

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - LGZ Warmer, Thermal, Infusion Fluid

All 25
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K121198.
Quantum Blood and IV Fluid Infusion Warmer
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BELMONT HYPERTHERMIA PUMP
K131519 · Belmont Instrument Corp. · Nov 2013
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011