510(k) · Cleared

Cleared

Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000

K092490510(k) AbbreviatedCleared Nov 4, 200983-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

STERIS Corporation · FLE Sterilizer, Steam

Cleared on Nov 4, 2009 as substantially equivalent to K082435 (STERIS Corporation, 2008) and 1 other predicate after an 83-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.

Decided: Nov 4, 2009
Review: 83 days
Class: Class II
Product code: FLE
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K010865 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
3 generations backK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
2 generations backK082435 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · Recalled
1 generation backK091136 Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009 · Recalled
This deviceK092490 Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000STERIS Corporation · 2009
Descendant · cites it directly · 0 of its ownK173493 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000STERIS Corporation · 2018

Most influential descendants

Showing 1 of 1 · See all

K173493Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000STERIS Corporation · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K010865	Amsco Century Medium Sterilizer, Model Century	STERIS Corporation	2001	1
−3	K020747	Amsco Century Medium Sterilizer 26 X 26	STERIS Corporation	2002	—
−2	K082435	Amsco Evolution Medium Steam Sterilizer	STERIS Corporation	2008	4
−1	K091136	Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200	STERIS Corporation	2009	3
0 (this device)	K092490	Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000	STERIS Corporation	2009	—
+1	K173493	Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000	STERIS Corporation	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K092490, 2001–2018Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K082435	Amsco Evolution Medium Steam Sterilizer Summary page 2 …nd HC-3000 Common/Usual Name: Steam Sterilizer Classification Name: Steam Sterilizer (21 CFR 880.6880, Product Code 80 FLE) Predicate Devices K082435, Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500) cleared December 30, 2008. K091136, Amsco Evolution Mediu…	STERIS Corporation	2008	4
*	K091136	Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 Summary page 2 …r (21 CFR 880.6880, Product Code 80 FLE) Predicate Devices K082435, Amsco Evolution Medium Steam Sterilizer (Models HC-600 and HC-1500) cleared December 30, 2008. K091136, Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) cleared June 29, 2009. Description of Device The Amsco E…	STERIS Corporation	2009	3

Also cleared against K082435: 3 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
K173493	Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000	STERIS Corporation	2018	0

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 8 years and passes through 1 company; a new generation was cleared every 12 months on median.
3 of the 4 ancestors have a recall of any class.
Of its descendants, K173493 (STERIS Corporation, 2018) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K082435.

How does its category compare?

All FLE devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Evolution Series Steam Sterilizer Models HC-2000 and HC-3000 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations: * Prevacuum - is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. * Steam Flush Pressure-Pulse(SFPP)- is equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. The Amsco Evolution…

Read the full statement (648 words)

* Prevacuum - is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART

(Bowie-Dick) cycles.

* Steam Flush Pressure-Pulse(SFPP)- is equipped with SFPP, Prevacuum,

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

The Amsco Evolution Series Prevacuum Steam Sterilizer is equipped with the following

factory-programmed sterilization cycles and cycle values (Table 4-1):

Table 4-1. Amsco Evolution Series Prevacuum Steam Sterilizer

factor -rorammed sterilization cycles and ycle values

Prevac 270° (132°C) 4 minutes 30 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each and

Fabric Packs. Refer to

Table 4-3 for recommended

quantities.

Prevac 2700 F (132°C) 4 minutes 5 minutes Single Fabric Pack

Gravity 250°F (121°C) 30 minutes 15 minutes Fabric Packs. Refer to

Table 4-3 for recommended

quantities.

Liquid* 250W (121 0 C) 45 minutes N/A Refer to Table 4-4for

recommended quantities.

Prevac 275F (135°C) 3 minutes 30 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 4-3for recommended

quantities.

"гиCycles~ sPa~ ~~~ ie~4%?fii~f~4•W

mmtS~iie,

Gravity 270F (132°C) 15 minutes 45 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 4-3for recommended

quantities.

Gravity 250°F (121°C) 30 minutes 45 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 4-3for recommended

quantities.

Gravity 270°F (132 0 C) 25 minutes 15 minutes Fabric Packs. Refer to

Table 4-3 for recommended

quantities.

DART 270° (132°C) 3 minutes 1 minute N/A

Warm-Up

DART 270° (132 0 C) 3 ½2 minutes 1 minute Bowie-Dick Test Pack,

DART Test Pack

Leak Test N/A N/A N/A N/A

*The liquid cycle is for non-patient contact use only.

The Amsco Evolution Series Steam Flush Pressure-Pulse(SFPP) Sterilizer is equipped

with the following factory-programmed sterilization cycles and cycle values (Table 4-2):

Table 4-2. Amsco Evolution Series Steam Flush Pressure-Pulse(SFPP)

Sterilizer factory- ro ammed sterilization c cles and c cle values

SFPP 270° (132 0 C) 4 minutes 45 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each and Fabric

Packs. Refer to Table 4-3 for

recommended quantities.

SFPP 275° (135°C) 3 minutes 45 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 4-3for recommended

quantities.

Ye Stenhize x~,Vw

»s~OStenze 3 .Eny Time;

ITm fip~eratureg.________

,*s

Prevac 270°F (132°C) 4 minutes 30 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each and Fabric

Packs. Refer to Table 4-3for

recommended quantities.

Gravity 250°F (121°C) 30 minutes 15 minutes Fabric Packs. Refer to Table

4-3for recommended

quantities.

SFPP 270F (132°C) 4 minutes 5 minutes Single Fabric Pack

Prevac 275F (135°C) 3 minutes 30 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 4-3for recommended

quantities.

Gravity 270F (132°C) 15 minutes 45 minutes Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 4-3 for recommended

quantities.

Liquid* 250° (121°C) 45 minutes N/A Refer to Table 4-4for

recommended quantities.

DART 270° (132 0 C) 3 minutes 1 minute N/A

Warm-Up

DART 270F (132 0 C) 3 ½2 minutes 1 minute Bowie-Dick Test Pack,

_______I_ DART Test Pack

Leak Test N/A N/A N/A N/A

*The liquid cycle is for non-patient contact use only.

The following table lists STERIS's recommended loads by sterilizer size:

Table 4-3. Amsco Evolution Series Steam

Sterilizer recommended loads per sterilizer size

26" x 61" x 49" HC-2000 15 40

26" x 61" x 72" HC-3000 25 60

The following table is a guideline for liquid cycle processing:

Table 4-4. Amsco Evolution Series Steam

Sterilizer Liquid Cycle Guideline

-Numfber~o4K' R~1~L.... '

13 L 1000 ml 45 minutes

The Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:

* ModelHC-2000 26"x61"x49"

· Model HGC-3000 26"x61"x72"

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092490 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092490: Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092490

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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

Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000

Line of descent and top descendants

Descendants by year cleared

What was it cleared against? (2)

What descends from it? (1)

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

What does this lineage say?

How does its category compare?

What is it indicated for?

Also cleared against K082435

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