510(k) · Cleared

Cleared

Amsco Evolution Medium Steam Sterilizer

K173481510(k) TraditionalCleared Mar 9, 2018116-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 Mar 9, 2018 as substantially equivalent to K091136 (STERIS Corporation, 2009) after a 116-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.

Decided: Mar 9, 2018
Review: 116 days
Class: Class II
Product code: FLE
Recalls: None
Predicates: 1

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 deviceK173481 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2018
Descendant · cites it directly · 0 of its ownK203061 Amsco Evolution Medium Steam Sterilizer (Models HC-900 and…STERIS Corporation · 2020

Most influential descendants

Showing 1 of 1 · See all

K203061Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated…STERIS Corporation · 2020 · 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)	K173481	Amsco Evolution Medium Steam Sterilizer	STERIS Corporation	2018	—
+1	K203061	Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution…	STERIS Corporation	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K173481, 2001–2020Source: 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
*	K091136	Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 Summary page 8 …880.6880 Product Code: FLE 2. Predicate Device AMSCO Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200), K091136. 3. Description of Device The Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 are de…	STERIS Corporation	2009	3

Also cleared against K091136: 1 other device →

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
K203061	Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated…	STERIS Corporation	2020	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 17 years and passes through 1 company; a new generation was cleared every 6.6 years on median.
3 of the 4 ancestors have a recall of any class.
Of its descendants, K203061 (STERIS Corporation, 2020) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K091136.

How does its category compare?

All FLE devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Medium Steam Sterilizer Models HC-900 and HC-1200 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 (728 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 Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):

Table 5-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values

Cycles Sterilize Sterilize Dry Time Recommended Load

Temperature Time

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 5-3 for recommended

quantities.

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

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

Table 5-3 for recommended

quantities.

Liquid® 250°F (121°C) | 45 minutes | N/A Refer to Table 5-4 for

recommended quantities.

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

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 5-3 for recommended

quantities.

Gravity 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped instrument

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 5-3 for recommended

quantities.

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

trays, maximum weight 25

lbs (11.3 kg) each. Refer to

Table 5-3 for recommended

quantities.

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

Table 5-3 for recommended

quantities.

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

Warm-Up

DART 270°F (132°C) | 3 ½ 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 Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-2):

Table 5-2. Amsco Evolution Medium Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle

Cycles Sterilize Sterlize Dry Time Recommended Load

Temperature Time

SFPP 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 5-3

for recommended

quantities.

SFPP 275°F (135°C) | 3 minutes 30 minutes | Double wrapped

instrument trays,

maximum weight 25 lbs

(11.3 kg) each. Refer to

Table 5-3 for

recommended quantities.

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 5-3

for recommended

quantities.

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

Table 5-3 for recommended quantities.

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

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

instrument trays,

maximum weight 25 lbs

(11.3 kg) each. Refer to

Table 5-3 for recommended quantities.

Gravity 270°F (132°C) | 15 minutes | 30 minutes | Double wrapped

instrument trays,

maximum weight 25 lbs

(11.3 kg) each. Refer to

Table 5-3 for recommended quantities.

Liquid’ 250°F (121°C) | 45 minutes | N/A Refer to Table 5-4 for

recommended quantities.

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

Warm-Up

DART 270°F (132°C) | 3 ½ 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 following table lists STERIS’s recommended loads by sterilizer size:

Table 5-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size

Sterilizer Size Wrapped Instrument Trays Fabric Packs

26” x 37 ½” x 42” 12 18

26” x 37 ½” x 54” 16 30

The following table is a guideline for liquid cycle processing:

Table 5-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle* Guideline

Number of Containers Volume of Liquid In One Container Minimum Recommended Sterilize Time at 250°F (121°C)

3 1000 ml 45 minutes

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

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

• 26” x 37½” x 42” (Model HC — 900)

• 26” x 37½” x 54” (Model HC — 1200)

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/K173481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173481: Amsco Evolution 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/K173481

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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 Medium Steam Sterilizer

Line of descent and top descendants

Descendants by year cleared

What was it cleared against? (1)

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 K091136

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