510(k) · Cleared
ClearedCastle Series 100 Steam Sterilizers (Straightline)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getinge/Castle, Inc. · FLE Sterilizer, Steam
Cleared on Nov 12, 1997 as substantially equivalent to K820783 (Sybron Corp., 1982) after a 246-day review. Its family tree reaches back 1 generation to 1982. 24 later devices descend from it.
- Decided
- Nov 12, 1997
- Review
- 246 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K820783 (1982). 24 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- This deviceK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- Descendant · cites it directly · 23 of its ownK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- Descendant · 2 generations on · 21 of its ownK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- Descendant · 3 generations on · 8 of its ownK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- Descendant · 3 generations on · 5 of its ownK070657 Getinge 633HC Series Vacuum/Gravity Steam SterilizerGetinge Sourcing, LLC · 2007
- Descendant · 4 generations on · 3 of its ownK172159 Getinge GSS67N Series Steam SterilizerMaquet GmbH · 2018
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K994314Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000 · cites it directly23descendants
- K012573Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HCGetinge/Castle, Inc. · 2001 · 2 generations on21descendants
- K030789Amsco Century Steam SterilizerSTERIS Corporation · 2003 · 3 generations on8descendants
- K070657Getinge 633HC Series Vacuum/Gravity Steam SterilizerGetinge Sourcing, LLC · 2007 · 3 generations on5descendants
- K172159Getinge GSS67N Series Steam SterilizerMaquet GmbH · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| 0 (this device) | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| +1 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| +2 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| +3 | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| +3 | K070657 | Getinge 633HC Series Vacuum/Gravity Steam Sterilizer | Getinge Sourcing, LLC | 2007 | — |
| +4 | K172159 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K820783 | Castle Microcomputer Sterilizer ControlSummary page 1…team Sterilizer (per 21 CFR 880.6880) Per 21CFR 807.92(a)(3) We believe this product to be substantially equivalent to our Castle Microcomputer Contros and Sterilizers K820783. Per 21CFR 807.92(a)(4), (5) & (6) The Castle Series 100 Sterilizers (Straightline) is an upgrade of an existing microcomputer… | 1982 |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994314 | Castle Series 100HC Steam Sterilizers | 2000 | 23 |
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?
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls intended to be used for the control of a variety of equipment including washers, washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the…
Read the full statement (401 words)
The Getinge/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls intended to be used for the control of a variety of equipment including washers, washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the Getinge/Castle (Straightline) line of steam sterilizer models (see attachment Section 18 - Competitive Comparison). The Series 100 (Straightline) sterilizer line includes two sizes, A 16” x 16” x 26” chamber having a volume 3.9 cubic feet and a 20” x 20” x 38” chamber having a volume 8.8 cubic feet. Both chamber sizes include single and double door sterilizers with a power door offered on the single door model only. The Series 100 Steam Sterilizer (Straightline) includes gravity (Model 122) and prevacuum (Model 133) steam sterilizers for healthcare facilities and moist heat (Model 123) sterilizes for laboratories and industrial uses. The latter applications are addressed in this submittal for the rare occasion health care facilities may use them. The to be cleared for each of the models are as follows:
For the Model 122
P1 - GRAV WRAP 1 - Gravity Cycle - 30 minute exposure at 250°F and 30 minute dry
P2 - GRAV WRAP 2 - Gravity Cycle - 10 minute exposure at 275°F and 30 minute dry
P3 - FLASH 3+ - Gravity Cycle with 3 minute exposure at 275°F and 0 minute dry
P4 - FLASH 10+ - Gravity Cycle with 10 minute exposure at 275°F and 0 minute dry
For the Model 123
P1 - GRAV WRAP 1 - Gravity Cycle - 30 minute exposure at 250°F and 30 minute dry
P4 - FLASH 3+ - Gravity Cycle - 3 minute exposure at 275°F and o minutes dry
For the Model 133
P1 - PREVA WRAP - Prevacuum Cycle - 3 minute exposure at 275°F and 16 minute dry
P2 - PREVA WRP1 - Prevacuum Cycle - 3 minute exposure at 275°F and 3 minute dry
P3 - FLASH 3+ - Gravity Cycle - 3 minute exposure at 275°F and 0 minute dry
P4 - FLASH 10+ - Gravity Cycle - 10 minute exposure at 275°F and 0 minute dry
P5 - VAC LEAK TST - Air leak Test - 3 minute exposure at 268°F and 15 min. leak test
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/K970907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970907: Castle Series 100 Steam Sterilizers (Straightline).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970907
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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