510(k) · Cleared
ClearedAmsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FLE Sterilizer, Steam
Cleared on Feb 23, 2018 as substantially equivalent to K092490 (STERIS Corporation, 2009) after a 102-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Feb 23, 2018
- Review
- 102 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010865 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK010865 Amsco Century Medium Sterilizer, Model CenturySTERIS Corporation · 2001 · Recalled
- 4 generations backK020747 Amsco Century Medium Sterilizer 26 X 26STERIS Corporation · 2002
- 3 generations backK082435 Amsco Evolution Medium Steam SterilizerSTERIS Corporation · 2008 · Recalled
- 2 generations backK091136 Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200STERIS Corporation · 2009 · Recalled
- 1 generation backK092490 Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000STERIS Corporation · 2009
- This deviceK173493 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000STERIS Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | 2001 | 1 |
| −4 | K020747 | Amsco Century Medium Sterilizer 26 X 26 | STERIS Corporation | 2002 | — |
| −3 | K082435 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2008 | 4 |
| −2 | K091136 | Amsco Evolution Medium Steam Sterilizer, Model HC-900 and HC-1200 | STERIS Corporation | 2009 | 3 |
| −1 | K092490 | Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000 | STERIS Corporation | 2009 | — |
| 0 (this device) | K173493 | Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 | STERIS Corporation | 2018 | — |
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 |
|---|---|---|---|
| * | K092490 | Amsco Evolution Series Steam Sterilizer, Model: HC-2000 and HC-3000Summary page 8…21 CFR 880.6880 Product Code: FLE 2. Predicate Device AMSCO Evolution Floorloader Steam Sterilizer (Models HC-2000 and HC-3000), K092490. 3. Description of Device The Amsco Evolution Floorloader Steam Sterilizer models HC-2000 and HC-3000 are designed… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 months on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All FLE devicesFLE 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
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 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 (701 words)
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 Series Prevacuum Steam Sterilizer is equipped with the following factory-programmed sterilization cycles and cycle values (Table 5-1):
Table 5-1. Amsco Evolution Series 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
Ibs (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
Ibs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities.
Gravity 270°F (132°C) 15 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
Ibs (11.3 kg) each. Refer to
Table 5-3 for recommended
quantities.
Gravity 250°F (121°C) 30 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
Ibs (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 Series 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 Series Steam Flush Pressure-Pulse (SFPP) Sterilizer factory-programmed sterilization cycles and cycle values
Cycles Sterilize Sterilize Dry Time Recommended Load
Temperature Time
SFPP 270°F (132°C) 4 minutes 45 minutes | Double wrapped instrument
trays, maximum weight 25
Ibs (11.3 kg) each and Fabric
Packs. Refer to Table 5-3 for
recommended quantities.
SFPP 275°F (135°C) 3 minutes 45 minutes | Double wrapped instrument
trays, maximum weight 25
Ibs (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
Ibs (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
Ibs (11.3 kg) each. Refer to
Table 4-3 for recommended
quantities.
Gravity 270°F (132°C) 15 minutes | 45 minutes | Double wrapped instrument
trays, maximum weight 25
Ibs (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 Series Steam Sterilizer recommended loads per sterilizer size
Sterilizer Size Wrapped Instrument Trays Fabric Packs
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 5-4. Amsco Evolution Series 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 Amsco Evolution Series Steam Sterilizer is offered in the following chamber sizes:
• Model HC - 2000 26” x 61” x 49”
• Model HC - 3000 26” x 61” x 72”
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/K173493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173493: Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173493
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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