510(k) · Cleared
ClearedGetinge 400HC-E / 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 12, 2013 as substantially equivalent to K120441 (Getinge Sourcing, LLC, 2012) and 1 other predicate after a 239-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Mar 12, 2013
- Review
- 239 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K820783 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 5 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 4 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 3 generations backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- 2 generations backK103504 Getinge 400HC/500HC Series Steam SterilizerGetinge Sourcing, LLC · 2011
- 1 generation backK120441 Getinge 700HC-E Series Steam SterilizerGetinge Sourcing, LLC · 2012
- This deviceK122071 Getinge 400HC-E / Series Steam SterilizerGetinge Sourcing, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −5 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −4 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −3 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| −2 | K103504 | Getinge 400HC/500HC Series Steam Sterilizer | Getinge Sourcing, LLC | 2011 | — |
| −1 | K120441 | Getinge 700HC-E Series Steam Sterilizer | Getinge Sourcing, LLC | 2012 | — |
| 0 (this device) | K122071 | Getinge 400HC-E / Series Steam Sterilizer | Getinge Sourcing, LLC | 2013 | — |
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? (2)
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 |
|---|---|---|---|
| * | K120441 | Getinge 700HC-E Series Steam SterilizerSummary page 1…Steam Sterilizer (80 FILE) Class 11,as listed per 21 CFR 880.6880 Predicate Device: Getinge Model 700HC-E Series Steam Sterilizer [K1 20441]1 Getinge Model 400HC/500HC Series Steam Sterilizer [K1 03504] Description of Device: The Getinge 400H… | 2012 |
| * | K103504 | Getinge 400HC/500HC Series Steam SterilizerSummary page 1…880.6880 Predicate Device: Getinge Model 700HC-E Series Steam Sterilizer [K1 20441]1 Getinge Model 400HC/500HC Series Steam Sterilizer [K1 03504] Description of Device: The Getinge 400HC-EI500HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture s… | 2011 |
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 31 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K120441.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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-E/500HC-E Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable item such as surgical instruments and linens by mean of pressurized steam.
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/K122071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122071: Getinge 400HC-E / Series Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122071
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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