510(k) · Cleared

Cleared

Getinge Series Warming Cabinet

K153713510(k) TraditionalCleared Jun 7, 2016166-day reviewClass I21 CFR 890.5950

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

Getinge Sourcing, LLC · LHC Warmer, Irrigation Solution

Cleared on Jun 7, 2016 as substantially equivalent to K092823 (STERIS Corporation, 2009) after a 166-day review. Its family tree reaches back 2 generations to 2000.

Decided: Jun 7, 2016
Review: 166 days
Class: Class I
Product code: LHC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K993797 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK993797 EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
1 generation backK092823 Amsco Warming CabinetSTERIS Corporation · 2009
This deviceK153713 Getinge Series Warming CabinetGetinge Sourcing, LLC · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K993797	EC-7701 Fluid Warming Cabinet	Enthermics Medical Systems, Inc.	2000	—
−1	K092823	Amsco Warming Cabinet	STERIS Corporation	2009	—
0 (this device)	K153713	Getinge Series Warming Cabinet	Getinge Sourcing, LLC	2016	—

FIG. 1 — Lineage of K153713, 2000–2016Source: 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.

Planning a device in LHC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

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
*	K092823	Amsco Warming Cabinet Summary page 4 …eries Warming Cabinet Common Name: Warmer, Irrigation Solution Device Classification: Unclassified Predicate Device: AMSCO Warming Cabinet [K092823] Description of Device: The Getinge Series Warming Cabinets are designed for warm storage of solutions and blankets used for pa…	STERIS Corporation	2009	—

Also cleared against K092823: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K092823.

How does its category compare?

All LHC devices

LHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · LHC

2in 2016

2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHC

Too few LHC 510(k)s in any year since 2007 to give a median.

Recalls per year · LHC

8in 2015

2007high 8 (2015) · low 0 (2007)2026

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

Adverse event reports per year · LHC

6in 2025

2007high 69 (2016) · low 0 (2023)2025

MAUDE reports naming product code LHC, 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	0	—	0	3
2008	1	—	0	5
2009	1	—	0	2
2010	0	—	0	1
2011	0	—	0	2
2012	0	—	0	5
2013	0	—	0	2
2014	2	—	0	4
2015	1	—	8	13
2016	2	—	0	69
2017	0	—	0	33
2018	0	—	0	30
2019	0	—	0	8
2020	0	—	0	4
2021	0	—	0	5
2022	0	—	0	1
2023	0	—	0	0
2024	0	—	0	5
2025	0	—	0	6
2026	0	—	0	—

What is it indicated for?

Getinge Series Warming Cabinet (models 5524, 5618, 5624) are designed for the heating and storage of irrigation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.

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/K153713 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153713: Getinge Series Warming Cabinet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153713

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