510(k) · Cleared
ClearedConsolidated HC Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consolidated Machine Corp. · FLE Sterilizer, Steam
Cleared on Aug 1, 2022 as substantially equivalent to K183410 (STERIS Corporation, 2019) after a 140-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 1, 2022
- Review
- 140 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010865 (2001). No later device cites it as a predicate yet.
- 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 deviceK220736 Consolidated HC Steam SterilizerConsolidated Machine Corp. · 2022
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) | K220736 | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | 2022 | — |
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 |
|---|---|---|---|
| * | K183410 | AMSCO 600 Steam SterilizerSummary page 7…Steam Sterilizer/Autoclave Classification Name: Sterilizer, Steam Classification Number: 21 CFR 880.6880 Product Code: FLE Predicate Device K183410 AMSCO 600 Steam Sterilizer Device Class: Class II Common Name: Steam Sterilizer/Autoclave Classification… | 2019 |
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 21 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K183410.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 R2018 for all models of the HC Series steam sterilizers are provided below. Table 1: Validated…
Read the full statement (480 words)
The Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 R2018 for all models of the HC Series steam sterilizers are provided below.
Table 1: Validated Sterilization Cycles
Cycle Type | Sterilization Temperature | Sterilization Time | Dry Time | Load Type
Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Fabric Packs
Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg)
Gravity – IUSS | 270°F (132°C) | 3 minutes | 1 minutes | Single Unwrapped Tray Maximum weight per tray: 25lbs (11.3 kg)
Gravity | 270°F (132°C) | 15 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg)
Pre-Vacuum – IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Single Unwrapped Tray Maximum weight per tray: 25lbs (11.3 kg)
Pre-Vacuum | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs
Pre-Vacuum | 270°F (132°C) | 4 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg)
Pre-Vacuum | 275°F (135°C) | 3 minutes | 30 minutes | Double Wrapped Instrument Trays Maximum weight per tray: 25lbs (11.3 kg)
Pre-Vacuum | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack and Single Unwrapped Tray Maximum weight per tray: 25lbs (11.3 kg)
Liquids | 250°F (121°C) | 30 minutes | N/A | 1L Liquid Volumes
Bowie Dick Test | 273°F (134°C) | 3.5 minutes | 0 minutes | Bowie Dick Test Pack
Vacuum Leak Test | 270°F (132°C) | N/A | N/A | Empty Chamber
Warm Up | 270°F (132°C) | 3 minutes | 1 minutes | Empty Chamber
Table 2: Load Size
Model | Sterilizer Chamber Size | Double Wrapped Instrument Trays | Fabric Packs2 | Number of Liquid Containers3
26AV-HC | 26” X 26” X 39” | 9, maximum weight 25lb each | 12 | 70, 1 Liter Volume Per Container
26BV-HC | 26” X 26” X 49” | 12, maximum weight 25lb each | 16 | 90, 1 Liter Volume Per Container
3AV-HC | 20” X 20” X 38” | 3, maximum weight 25lb each | 9 | 28, 1 Liter Volume Per Container
1 For instrument trays, the maximum weight per tray is 25lbs (11.3 kg).
2 The weight of each fabric pack should be limited to approximately 3.2 lbs (1.4 kg) with a density of 11.3 lb/ft3 (181 kg/m3) or less.
3 For liquid containers, the maximum volume of liquid per container is 1,000 ml. Please note, liquid loads processed in the sterilizer are inappropriate for direct patient contact.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220736: Consolidated HC 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/K220736
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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