Cleared Traditional

K012832 - COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200

Also marketed or referenced as:
COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

K012832 is an FDA 510(k) clearance for COMFORTMATE FLUID WARMING SYSTEM, manufactured by Nxstage Medical, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K012832 · Nxstage Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
62d
Days
Class 2
Risk

K012832 is an FDA 510(k) clearance for the COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 62 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 Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K012832

510(k) Number K012832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date October 24, 2001
Days to Decision 62 days
Submission Type Traditional
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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 K012832.
HYPERTHERMIA PUMP
K070654 · Belmont Instrument Corp. · Jun 2007
LARGE VOLUME FLUID RESERVOIR
K032778 · Belmont Instrument Corp. · Sep 2003
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
K032674 · Belmont Instrument Corp. · Sep 2003
INFUSION FLUID WARMER
K883873 · Pmt Corp. · Feb 1989
BT 794-BLOOD/FLUID WARMER
K822098 · Electromedics, Inc. · Aug 1982