510(k) · Cleared

Recalled · Class II · 2019

Amsco Chimeron Medium Steam Sterilizer

K112055510(k) TraditionalCleared Dec 16, 2011150-day reviewClass II21 CFR 880.6880Recalls 2

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

STERIS Corporation · FLE Sterilizer, Steam

Cleared on Dec 16, 2011 as substantially equivalent to K010865 (STERIS Corporation, 2001) after a 150-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 2 times.

Decided: Dec 16, 2011
Review: 150 days
Class: Class II
Product code: FLE
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K010865 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
This deviceK112055 Amsco Chimeron Medium Steam SterilizerSTERIS Corporation · 2011
Descendant · cites it directly · 0 of its ownK212424 AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation · 2021

Most influential descendants

Showing 1 of 1 · See all

K212424AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010865	Amsco Century Medium Sterilizer, Model Century	STERIS Corporation	2001	1
0 (this device)	K112055	Amsco Chimeron Medium Steam Sterilizer	STERIS Corporation	2011	—
+1	K212424	AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers	STERIS Corporation	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K112055, 2001–2021Source: 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

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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
*	K010865	Amsco Century Medium Sterilizer, Model Century Summary page 2 …Sterilizer Classification Name:. Steam Sterilizer (21 CFR 880.6880) Product Code FLE 2. Predicate Device K010865, AMSCO Century Medium Steam Sterilizer, product code [FLE] cleared May 31s0, 200 1. 3. Description of Device The A…	STERIS Corporation	2001	1

Also cleared against K010865: 2 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
K212424	AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers	STERIS Corporation	2021	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 22, 2019	Class II	Z-0586-2020	Process control	The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward
Feb 19, 2015	Class II	Z-1561-2015	Software design (manufacturing process)	STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K212424 (STERIS Corporation, 2021) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K010865.

How does its category compare?

All FLE devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

The AMSCO Chimeron Medium Steam Sterilizers (Models 36H, 48H, 60H, 365L, 48SL, 605L, 36CH, 48CH, 60CH, 36C5L, 48CSL and 60CSL) are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in the following configuration:

Prevacuum - equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112055 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112055: Amsco Chimeron Medium Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112055

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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