510(k) · Cleared
ClearedGetinge 633HC Series Vacuum/Gravity 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 Apr 5, 2007 as substantially equivalent to K012573 (Getinge/Castle, Inc., 2001) after a 27-day review. Its family tree reaches back 4 generations to 1982. 5 later devices descend from it.
- Decided
- Apr 5, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K820783 (1982). 5 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 deviceK070657 Getinge 633HC Series Vacuum/Gravity Steam SterilizerGetinge Sourcing, LLC · 2007
- Descendant · cites it directly · 3 of its ownK172159 Getinge GSS67N Series Steam SterilizerMaquet GmbH · 2018
- Descendant · 2 generations on · 1 of its ownK201927 Getinge GSS610N Series Steam SterilizerMaquet GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK252307 Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company) · 2026
- Descendant · 3 generations on · 0 of its ownK214120 GSS610N21 Series Steam SterilizerMaquet GmbH · 2022
- Descendant · cites it directly · 0 of its ownK120532 Getinge 633HC Steam Sterilizer Air Glide SystemGetinge Sourcing, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K172159Getinge GSS67N Series Steam SterilizerMaquet GmbH · 2018 · cites it directly3descendants
- K201927Getinge GSS610N Series Steam SterilizerMaquet GmbH · 2021 · 2 generations on1descendant
- K252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company) · 2026 · 2 generations on0descendants
- K214120GSS610N21 Series Steam SterilizerMaquet GmbH · 2022 · 3 generations on0descendants
- K120532Getinge 633HC Steam Sterilizer Air Glide SystemGetinge 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) | K070657 | Getinge 633HC Series Vacuum/Gravity Steam Sterilizer | Getinge Sourcing, LLC | 2007 | — |
| +1 | K172159 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH | 2018 | — |
| +2 | K201927 | Getinge GSS610N Series Steam Sterilizer | Maquet GmbH | 2021 | — |
| +2 | K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | 2026 | — |
| +3 | K214120 | GSS610N21 Series Steam Sterilizer | Maquet GmbH | 2022 | — |
| +1 | K120532 | Getinge 633HC Steam Sterilizer Air Glide System | Getinge Sourcing, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HCSummary page 3…ments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam. Predicate Device Getinge 400HC/500HC Series Steam Sterilizers [K012573]. Nonclinical Comparisons to Predicate Device In summary, the differences between the 633HC Series and the predicate 400HC/500HC… | 2001 |
What descends from it? (5)
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 25 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K172159 (Maquet GmbH, 2018) has gone furthest, with 3 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. 2007, 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 Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070657: Getinge 633HC Series Vacuum/Gravity 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/K070657
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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