510(k) · Cleared
Recalled · Class II · 2018Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FLE Sterilizer, Steam
Cleared on Jun 29, 2009 as substantially equivalent to K082435 (STERIS Corporation, 2008) after a 70-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 29, 2009
- Review
- 70 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010865 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
- 2 generations backK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
- 1 generation backK082435 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · Recalled
- This deviceK091136 Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009
- Descendant · cites it directly · 1 of its ownK173481 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2018
- Descendant · cites it directly · 1 of its ownK092490 Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000STERIS Corporation · 2009
- Descendant · 2 generations on · 0 of its ownK203061 Amsco Evolution Medium Steam Sterilizer (Models HC-900 and…STERIS Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK173493 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000STERIS Corporation · 2018
Most influential descendants
Showing 4 of 4 · See all- K173481Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2018 · cites it directly1descendant
- K092490Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000STERIS Corporation · 2009 · cites it directly1descendant
- K203061Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated…STERIS Corporation · 2020 · 2 generations on0descendants
- K173493Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000STERIS Corporation · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | 2001 | 1 |
| −2 | K020747 | Amsco Century Medium Sterilizer 26 X 26 | STERIS Corporation | 2002 | — |
| −1 | K082435 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2008 | 4 |
| 0 (this device) | K091136 | Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 | STERIS Corporation | 2009 | — |
| +1 | K173481 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2018 | — |
| +1 | K092490 | Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000 | STERIS Corporation | 2009 | — |
| +2 | K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution… | STERIS Corporation | 2020 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K082435 | Amsco Evolution Medium Steam SterilizerSummary page 2…Classification Name: Steam Sterilizer (21 CFR 880.6880) Product Code 80 FLE 2. Predicate Device K082435, Amsco Evolution Medium Steam Sterilizer, product code [FLE] cleared December 30, 2008. 3. Description of Devic… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2018 | Class II | Z-0824-2019 | Device Design | The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side. |
| Oct 18, 2013 | Class II | Z-0478-2014 | Device Design | The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. |
| Mar 23, 2012 | Not classified | Z-1522-2012 | Device Design | Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues… |
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.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K173481 (STERIS Corporation, 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K082435.
How does its category compare?
All FLE devicesFLE 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 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 (638 words)
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 Medium Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 4-1):
Table 4-1. Amsco Evolution Medium Prevacuum Steam Sterilizer factory-programmed sterilization cycles and cycle values
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 4-3 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 4-3 for recommended quantities.
Liquid 250°F (121°C) 45 minutes N/A Refer to Table 4-4 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 4-3 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 4-3 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 4-3 for recommended quantities.
Gravity 270°F (132°C) 25 minutes 15 minutes Fabric Packs. Refer to Table 4-3 for recommended quantities.
DART Warm-Up 270°F (132°C) 3 minutes 1 minute N/A
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 4-2):
Table 4-2. Amsco Evolution Medium Steam Flush Pressure-Pulse(SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
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 4-3 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 4-3 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 4-3 for recommended quantities.
Gravity 250°F (121°C) 30 minutes 15 minutes Fabric Packs. Refer to Table 4-3 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 4-3 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 4-3 for recommended quantities.
Liquid 250°F (121°C) 45 minutes N/A Refer to Table 4-4 for recommended quantities.
DART Warm-Up 270°F (132°C) 3 minutes 1 minute N/A
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 4-3. Amsco Evolution Medium Steam Sterilizer recommended loads per sterilizer size
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 4-4. Amsco Evolution Medium Steam Sterilizer Liquid Cycle* Guideline
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 as stated in the FDA summary.
https://510kreport.com/device/K091136 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091136: Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091136
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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