510(k) · Cleared

Recalled · Class II · 2025

Ranger Irrigation Fluid Warming System

K060939510(k) TraditionalCleared Jun 26, 200681-day reviewClass II21 CFR 880.5725Recalls 1

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

Arizant Healthcare, Inc. · LGZ Warmer, Thermal, Infusion Fluid

Cleared on Jun 26, 2006 as substantially equivalent to K973741 (Augustine Medical, Inc., 1998) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1987. 2 of the 12 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled once.

Decided: Jun 26, 2006
Review: 81 days
Class: Class II
Product code: LGZ
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K873435 (1987). 3 ancestors in all. 8 later devices descend from it, 2 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK873435 Level 1 IR-600 Normothermic Irrigating SetLevel 1 Technologies, Inc. · 1987
This deviceK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006
Descendant · cites it directly · 7 of its ownK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008 · Recalled (Class I)
Descendant · cites it directly · 4 of its ownK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
Descendant · 2 generations on · 3 of its ownK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
Descendant · 2 generations on · 2 of its ownK172048 FluidSmartThermedx, LLC · 2017 · Recalled
Descendant · 2 generations on · 0 of its ownK262532 NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601…ICU Medical · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008high 2 (2026) · low 0 (2009)2026

Class I recalls in this family

K973741 Bair Hugger Blood/Fluid Warmerdirect predicate · 1998
K072080 Normoflo Irrigation Fluid Warmer, Models H-1100…cites it directly · 2008

Most influential descendants

Showing 5 of 8 · See all

K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Smiths Medical Asd, Inc. · 2008 · cites it directly7descendants
K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · cites it directly4descendants
K133799Thermedx Fluid Managment SystemThermedx, LLC · 2014 · 2 generations on3descendants
K172048FluidSmartThermedx, LLC · 2017 · 2 generations on2descendants
K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K873435	Level 1 IR-600 Normothermic Irrigating Set	Level 1 Technologies, Inc.	1987	—
0 (this device)	K060939	Ranger Irrigation Fluid Warming System	Arizant Healthcare, Inc.	2006	—
+1	K072080	Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation…	Smiths Medical Asd, Inc.	2008	Class I
+1	K091939	Thermedx Prodigy Fluid Management System, Models P1000, P2000	Thermedx, LLC	2010	2
+2	K133799	Thermedx Fluid Managment System	Thermedx, LLC	2014	2
+2	K172048	FluidSmart	Thermedx, LLC	2017	1
+2	K262532	NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501…	ICU Medical	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1998	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	1
2010	1	0
2014	1	0
2016	1	0
2017	1	0
2021	1	0
2026	2	0

FIG. 1 — Lineage of K060939, 1987–2026Source: 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.

2 devices in this family have 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K973741	Bair Hugger Blood/Fluid Warmer Summary page 4 …m Common/Usual Name Irrigation Fluid Warmer Classification Name Warmer, Irrigation Solution Predicate Devices Arizant Healthcare Inc. Bair Hugger Blood/Fluid Warmer (K973741) Arizant Healthcare Inc. Bair Hugger Patient Warming System (K933726) Smiths Level \| IR-600 Normothermic Irrigating Set (K873435)…	Augustine Medical, Inc.	1998	Class I
*	K933726	Modification of Bair Hugger Patient Warming System Summary page 4 …mer, Irrigation Solution Predicate Devices Arizant Healthcare Inc. Bair Hugger Blood/Fluid Warmer (K973741) Arizant Healthcare Inc. Bair Hugger Patient Warming System (K933726) Smiths Level \| IR-600 Normothermic Irrigating Set (K873435) Description of Device The Ranger Irrigation Fluid Warming System c…	Augustine Medical, Inc.	1994	—
*	K873435	Level 1 IR-600 Normothermic Irrigating Set Summary page 4 …are Inc. Bair Hugger Blood/Fluid Warmer (K973741) Arizant Healthcare Inc. Bair Hugger Patient Warming System (K933726) Smiths Level \| IR-600 Normothermic Irrigating Set (K873435) Description of Device The Ranger Irrigation Fluid Warming System consists of a warming device and an irrigation fluid warming…	Level 1 Technologies, Inc.	1987	—

Also cleared against K973741: 6 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072080	Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming… Class I	Smiths Medical Asd, Inc.	2008	7
K091939	Thermedx Prodigy Fluid Management System, Models P1000, P2000	Thermedx, LLC	2010	4

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 22, 2025	Class II	Z-2231-2025	Device Design	Notice was issued to clarify flow rates related to the inlet fluid temperature.

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 · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40…Smiths Medical Asd, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K072080 (Smiths Medical Asd, Inc., 2008) has gone furthest, with 7 descendants 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 Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.

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/K060939 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060939: Ranger Irrigation Fluid Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060939

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026