510(k) · Cleared

Cleared

Ranger Rapid Flow Blood/Fluid Warming System

K082217510(k) TraditionalCleared Oct 6, 200861-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

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

Cleared on Oct 6, 2008 as substantially equivalent to K973741 (Augustine Medical, Inc., 1998) after a 61-day review. Its family tree reaches back 1 generation to 1998. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Oct 6, 2008
Review: 61 days
Class: Class II
Product code: LGZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K973741 (1998). 1 later device descends from it, 1 citing it directly. 1 of the 3 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 deviceK082217 Ranger Rapid Flow Blood/Fluid Warming SystemArizant Healthcare, Inc. · 2008
Descendant · cites it directly · 0 of its ownK152946 TempedySeiratherm GmbH · 2016

Class I recalls in this family

K973741 Bair Hugger Blood/Fluid Warmerdirect predicate · 1998

Most influential descendants

Showing 1 of 1 · See all

K152946TempedySeiratherm GmbH · 2016 · cites it directly0descendants

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)	K082217	Ranger Rapid Flow Blood/Fluid Warming System	Arizant Healthcare, Inc.	2008	—
+1	K152946	Tempedy	Seiratherm GmbH	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K082217, 1998–2016Source: 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? (2)

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 …Blood/Fluid Warmer with Prcssure Infusor Classification Name Warmer, Thermal, Infusion Fluid Predicate Devices Arizant Healthcare Inc. Bair Hugger blood/fluid warmer (K973741) Leve! 1® H-1028 Fluid Warming System (BK020043) Intended Use The Ranger Rapid Flow blood/fluid warming system is intcnded to d…	Augustine Medical, Inc.	1998	Class I
Kept off the family tree	K020043	FDA’s K020043 is 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex… The summary prints BK020043, a CBER number, which our reading took as K020043, FDA’s number for 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM… (Arthrex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Level 1 H-1028 Fluid Warming System”. Kept off the family tree. Summary page 4 …fication Name Warmer, Thermal, Infusion Fluid Predicate Devices Arizant Healthcare Inc. Bair Hugger blood/fluid warmer (K973741) Leve! 1® H-1028 Fluid Warming System (BK020043) Intended Use The Ranger Rapid Flow blood/fluid warming system is intcnded to deliver warm blood, blood products, and liquids t…	Arthrex, Inc.	2002	—

Also cleared against K973741: 6 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K152946	Tempedy	Seiratherm GmbH	2016	0

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?

Its one ancestor has a recall, Class I.
Of its descendants, K152946 (Seiratherm GmbH, 2016) has gone furthest, with 0 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. 2008, this device’s year, is highlighted.

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 Rapid Flow blood/fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

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/K082217 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082217: Ranger Rapid Flow Blood/Fluid Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082217

Report an extraction error

Are you the manufacturer?

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