510(k) · Cleared
ClearedGetinge 400HC/500HC Series Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getinge Sourcing, LLC · FLE Sterilizer, Steam
Cleared on Mar 16, 2011 as substantially equivalent to K012573 (Getinge/Castle, Inc., 2001) after a 110-day review. Its family tree reaches back 4 generations to 1982. 3 later devices descend from it.
- Decided
- Mar 16, 2011
- Review
- 110 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K820783 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 3 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 2 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 1 generation backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- This deviceK103504 Getinge 400HC/500HC Series Steam SterilizerGetinge Sourcing, LLC · 2011
- Descendant · cites it directly · 2 of its ownK120441 Getinge 700HC-E Series Steam SterilizerGetinge Sourcing, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK122625 Getinge 800HC- Series Steam SterilizerGetinge Sourcing, LLC · 2013
- Descendant · cites it directly · 0 of its ownK122071 Getinge 400HC-E / Series Steam SterilizerGetinge Sourcing, LLC · 2013
Most influential descendants
Showing 3 of 3 · See all- K120441Getinge 700HC-E Series Steam SterilizerGetinge Sourcing, LLC · 2012 · cites it directly2descendants
- K122625Getinge 800HC- Series Steam SterilizerGetinge Sourcing, LLC · 2013 · 2 generations on0descendants
- K122071Getinge 400HC-E / Series Steam SterilizerGetinge Sourcing, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −3 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −2 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −1 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| 0 (this device) | K103504 | Getinge 400HC/500HC Series Steam Sterilizer | Getinge Sourcing, LLC | 2011 | — |
| +1 | K120441 | Getinge 700HC-E Series Steam Sterilizer | Getinge Sourcing, LLC | 2012 | — |
| +2 | K122625 | Getinge 800HC- Series Steam Sterilizer | Getinge Sourcing, LLC | 2013 | — |
| +1 | K122071 | Getinge 400HC-E / Series Steam Sterilizer | Getinge Sourcing, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HCSummary page 1…ation: Steam Sterilizer (80 FLE) Class 11,as listed per 21 CFR 880.6880 Predicate Device: Model 400HC/500HC Series Steam Sterilizer [K012573] Description of Device: The Getinge Models 422HC, 433HC, 522H0 and 533HC steam sterilizers are the same model designations as… | 2001 |
What descends from it? (3)
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)
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 29 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120441 (Getinge Sourcing, LLC, 2012) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K012573.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Getinge 400HC/500HC Series Steam Sterilizer is intended for use by
health care facilities and to be used to sterilize wrapped and unwrapped, porous and nonporous
heat and moisture stable items such as surgical instruments and linens by means of pressurized
steam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103504: Getinge 400HC/500HC Series 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/K103504
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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