510(k) · Cleared

Cleared

AMSCO 600 Medium Steam Sterilizer

K211500510(k) TraditionalCleared Aug 25, 2021103-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 Aug 25, 2021 as substantially equivalent to K183410 (STERIS Corporation, 2019) after a 103-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.

Decided: Aug 25, 2021
Review: 103 days
Class: Class II
Product code: FLE
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K010865 (2001). 2 later devices descend 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 backK112403 Amsco Chimeron Medium Steam SterlilzerSTERIS Corporation · 2012 · Recalled
1 generation backK183410 AMSCO 600 Steam SterilizerSTERIS Corporation · 2019
This deviceK211500 AMSCO 600 Medium Steam SterilizerSTERIS Corporation · 2021
Descendant · cites it directly · 1 of its ownK222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
Descendant · 2 generations on · 0 of its ownK222849 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022

Most influential descendants

Showing 2 of 2 · See all

K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · cites it directly1descendant
K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 2 generations on0descendants

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	K112403	Amsco Chimeron Medium Steam Sterlilzer	STERIS Corporation	2012	1
−1	K183410	AMSCO 600 Steam Sterilizer	STERIS Corporation	2019	—
0 (this device)	K211500	AMSCO 600 Medium Steam Sterilizer	STERIS Corporation	2021	—
+1	K222543	AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System…	Steris	2022	—
+2	K222849	AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System…	Steris	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	2	0

FIG. 1 — Lineage of K211500, 2001–2022Source: 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
*	K183410	AMSCO 600 Steam Sterilizer Summary page 6 …Sterilizer Automated Loading System Classification Number: 21 CFR 880.6880 Product Code: FLE, PEC 2. Predicate Device K183410 AMSCO 600 Steam Sterilizer 3. Description of Device The AMSCO 600 Steam Sterilizer uses saturated steam, gener…	STERIS Corporation	2019	—

Also cleared against K183410: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K222543	AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…	Steris	2022	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 20 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K222543 (Steris, 2022) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K183410.

How does its category compare?

All FLE devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1): Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values Cycles: Prevac, Prevac, Prevac, Prevac, Prevac, Prevac-IUSS, Gravity, Warm-Up, DART, Leak Test. Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size…

Read the full statement (135 words)

Table 1. AMSCO 600 Steam Sterilizer factory-validated sterilization cycles and cycle values

Cycles: Prevac, Prevac, Prevac, Prevac, Prevac, Prevac-IUSS, Gravity, Warm-Up, DART, Leak Test.

Table 2 AMSCO 600 Steam Sterilizer full load per sterilizer size

Sterilizer Size: 26” x 26” x 39”, 26” x 26” x 51”, 26” x 26” x 63”.

The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K211500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K211500: AMSCO 600 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/K211500

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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