510(k) · Cleared

Cleared

Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC

K012573510(k) SpecialCleared Sep 5, 200127-day reviewClass II21 CFR 880.6880

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

Getinge/Castle, Inc. · FLE Sterilizer, Steam

Cleared on Sep 5, 2001 as substantially equivalent to K994314 (Getinge/Castle, Inc., 2000) after a 27-day review. Its family tree reaches back 3 generations to 1982. 21 later devices descend from it.

Decided: Sep 5, 2001
Review: 27 days
Class: Class II
Product code: FLE
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K820783 (1982). 21 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
2 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
1 generation backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
This deviceK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
Descendant · cites it directly · 8 of its ownK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
Descendant · cites it directly · 5 of its ownK070657 Getinge 633HC Series Vacuum/Gravity Steam SterilizerGetinge Sourcing, LLC · 2007
Descendant · 2 generations on · 3 of its ownK172159 Getinge GSS67N Series Steam SterilizerMaquet GmbH · 2018
Descendant · 2 generations on · 3 of its ownK111223 Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011 · Recalled
Descendant · cites it directly · 3 of its ownK103504 Getinge 400HC/500HC Series Steam SterilizerGetinge Sourcing, LLC · 2011

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002high 4 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 21 · See all

K030789Amsco Century Steam SterilizerSTERIS Corporation · 2003 · cites it directly8descendants
K070657Getinge 633HC Series Vacuum/Gravity Steam SterilizerGetinge Sourcing, LLC · 2007 · cites it directly5descendants
K172159Getinge GSS67N Series Steam SterilizerMaquet GmbH · 2018 · 2 generations on3descendants
K111223Amsco Chimeron Small Steam SterilizerSTERIS Corporation · 2011 · 2 generations on3descendants
K103504Getinge 400HC/500HC Series Steam SterilizerGetinge Sourcing, LLC · 2011 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K820783	Castle Microcomputer Sterilizer Control	Sybron Corp.	1982	—
−2	K970907	Castle Series 100 Steam Sterilizers (Straightline)	Getinge/Castle, Inc.	1997	—
−1	K994314	Castle Series 100HC Steam Sterilizers	Getinge/Castle, Inc.	2000	—
0 (this device)	K012573	Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and…	Getinge/Castle, Inc.	2001	—
+1	K030789	Amsco Century Steam Sterilizer	STERIS Corporation	2003	—
+1	K070657	Getinge 633HC Series Vacuum/Gravity Steam Sterilizer	Getinge Sourcing, LLC	2007	—
+2	K172159	Getinge GSS67N Series Steam Sterilizer	Maquet GmbH	2018	—
+2	K111223	Amsco Chimeron Small Steam Sterilizer	STERIS Corporation	2011	3
+1	K103504	Getinge 400HC/500HC Series Steam Sterilizer	Getinge Sourcing, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2007	1	0
2011	2	0
2012	2	0
2013	4	0
2014	2	0
2018	1	0
2021	2	0
2022	1	0
2023	2	0
2026	1	0

FIG. 1 — Lineage of K012573, 1982–2026Source: 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.

Planning a device in FLE? 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 FLE device

#1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 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? (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
*	K994314	Castle Series 100HC Steam Sterilizers Summary page 1 …izer Models: 422HC, 433HC, 522HC and 533HC Stearn Sterilizer Steam Sterilizer (80 FLE) Class \|\|, as listed per 21 CFR 880.6880 Castle® Series 100HC Steam Sterilizer [K994314] and Table 2 for gravity sterilizers (Models 422HC and 522HC). (Continued...) Gatinge/Castle, Inc. FDA 510(k)…	Getinge/Castle, Inc.	2000	—

Also cleared against K994314: 1 other device →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K030789	Amsco Century Steam Sterilizer	STERIS Corporation	2003	8
K070657	Getinge 633HC Series Vacuum/Gravity Steam Sterilizer	Getinge Sourcing, LLC	2007	5
K103504	Getinge 400HC/500HC Series Steam Sterilizer	Getinge Sourcing, LLC	2011	3
K020590	Model 733HC Gravity/Vacuum Steam Sterilizer	Getinge/Castle, Inc.	2002	1

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 19 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K030789 (STERIS Corporation, 2003) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K994314.

How does its category compare?

All FLE devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLE

4in 2025

2007high 10 (2022) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLE

184in 2025

2007high 302 (2015) · low 67 (2007)2026

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

Recalls per year · FLE

1in 2021

2007high 2 (2013) · low 0 (2009)2026

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

Adverse event reports per year · FLE

71in 2025

2007high 113 (2014) · low 19 (2007)2025

MAUDE reports naming product code FLE, 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	5	67	1	19
2008	1	—	1	21
2009	8	109	0	19
2010	2	—	0	20
2011	5	141	1	63
2012	5	111	1	69
2013	5	241	2	112
2014	2	—	0	113
2015	3	302	1	68
2016	1	—	0	76
2017	3	233	0	63
2018	8	146	1	90
2019	5	192	2	91
2020	2	—	0	87
2021	5	147	1	81
2022	10	133	0	70
2023	7	88	0	66
2024	2	—	0	64
2025	4	184	0	71
2026	3	85	1	—

What is it indicated for?

Castle® 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and

to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids

not intended for direct patient contact) by means of pressurized steam.

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/K012573 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012573

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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