Cleared Traditional

K012832 - COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200 (FDA 510(k) Clearance)

Also includes:
COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K012832.
°M Warmer System with °M Station
K260988 · Mequ A/S · Apr 2026
Fluido Compact System
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Fluido® AirGuard System
K251733 · The Surgical Company International BV (As Tsc Life) · Sep 2025
°M Warmer System
K232107 · Mequ A/S · May 2024
Fluido Compact Blood and Fluid Warming System
K211618 · The Surgical Company International B.V. · Jun 2023
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
K211800 · Quality IN Flow , Ltd. · Dec 2022