510(k) · Cleared

Cleared

Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable Warming Set, Model #FWS-200

K012832510(k) TraditionalCleared Oct 24, 200162-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nxstage Medical, Inc. · LGZ Warmer, Thermal, Infusion Fluid

Cleared on Oct 24, 2001 as substantially equivalent to K973741 (Augustine Medical, Inc., 1998) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1998. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Oct 24, 2001
Review: 62 days
Class: Class II
Product code: LGZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K973741 (1998). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK973741 Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · Recalled (Class I)
This deviceK012832 Comfortmate Fluid Warming System, Model # FW-200; Comfortmate…Nxstage Medical, Inc. · 2001
Descendant · cites it directly · 1 of its ownK071263 Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc. · 2007 · Recalled
Descendant · 2 generations on · 0 of its ownK140623 Nxstage Express Fluid WarmerNxstage Medical, Inc. · 2014

Class I recalls in this family

K973741 Bair Hugger Blood/Fluid Warmerdirect predicate · 1998

Most influential descendants

Showing 2 of 2 · See all

K071263Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc. · 2007 · cites it directly1descendant
K140623Nxstage Express Fluid WarmerNxstage Medical, Inc. · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973741	Bair Hugger Blood/Fluid Warmer	Augustine Medical, Inc.	1998	Class I
0 (this device)	K012832	Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable…	Nxstage Medical, Inc.	2001	—
+1	K071263	Nxstage Travel Warmer, Models TW-400 & FWS-500	Nxstage Medical, Inc.	2007	1
+2	K140623	Nxstage Express Fluid Warmer	Nxstage Medical, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2014	1	0

FIG. 1 — Lineage of K012832, 1998–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LGZ device

#1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K973741	Bair Hugger Blood/Fluid Warmer Summary page 4 …nfusion Fluid C. Predicate Device Name: The predicate devices for the ComfortMate™ Fluid Warming System are the following: Warmer: Bair Hugger® Blood/Fluid Warmer - #K973741 (4/30/98); e MaxOne™ IV Fluid/Blood Warmer - #K002409 (6/28/01); * Medi-Temp Il FW300 Blood/Fluid Warmer — Originally 510(k)-cl…	Augustine Medical, Inc.	1998	Class I
*	K002409	Maxone, Blood, Blood Products and IV Fluid Warmer Summary page 4 …devices for the ComfortMate™ Fluid Warming System are the following: Warmer: Bair Hugger® Blood/Fluid Warmer - #K973741 (4/30/98); e MaxOne™ IV Fluid/Blood Warmer - #K002409 (6/28/01); * Medi-Temp Il FW300 Blood/Fluid Warmer — Originally 510(k)-cleared as the Dupaco CounterFlo 300 Blood/Fluid Warmer S…	Automatic Medical Technologies, Inc.	2001	—
Kept off the family tree	K950038	Medi-Temp II FW300 Blood/Fluid Warmer (originally cleared as the Dupaco… Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4 …V Fluid/Blood Warmer - #K002409 (6/28/01); * Medi-Temp Il FW300 Blood/Fluid Warmer — Originally 510(k)-cleared as the Dupaco CounterFlo 300 Blood/Fluid Warmer System - #K950038. Warmer Disposable: e Bair Hugger® Blood/Fluid Warmer - #K973741 (4/30/98); Medi-Temp Il FW300 Blood/Fiuid Warmer — Originally…

Also cleared against K973741: 6 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071263	Nxstage Travel Warmer, Models TW-400 & FWS-500	Nxstage Medical, Inc.	2007	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K071263 (Nxstage Medical, Inc., 2007) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K973741.

How does its category compare?

All LGZ devices

LGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGZ

2in 2025

2007high 7 (2012) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LGZ

546in 2022

2007high 546 (2022) · low 77 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LGZ

1in 2016

2007high 8 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LGZ

376in 2025

2007high 1,548 (2022) · low 10 (2008)2025

MAUDE reports naming product code LGZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	11
2008	4	99	0	10
2009	2	—	1	12
2010	2	—	1	43
2011	3	77	8	54
2012	7	162	0	52
2013	5	143	0	16
2014	0	—	0	23
2015	2	—	1	34
2016	2	—	1	15
2017	2	—	0	58
2018	1	—	0	94
2019	3	209	0	340
2020	0	—	0	1,221
2021	0	—	0	885
2022	3	546	0	1,548
2023	1	—	0	1,033
2024	1	—	0	862
2025	2	—	0	376
2026	2	—	1	—

What is it indicated for?

The ComfortMate™ Filuid Warming System is intended to be used for the warming of fluids prior to administration.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012832 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012832: Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable Warming Set, Model #FWS-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012832

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026