510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012832Substantially Equivalent

Comfortmate Fluid Warming System, Model # Fw-200; Comfortmate Disporsable Disposable Warming Set, Model #Fws-200

NxStage Medical Inc, Lawrence MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012832 is the FDA 510(k) clearance record for COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200, a class II device, cleared for Nxstage Medical, Inc. on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list 51 510(k) clearances for Nxstage Medical, Inc., from to . As of , FDA records show no recalls naming K012832.

Clearance record

Decision date
Received
(62 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Nxstage Medical, Inc. 439 S. Union St., Lawrence MA
510(k) summary
Summary
Third party review
No

Clearances, product code LGZ

Trailing 12 months
3 clearances under product code LGZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LGZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260