510(k) · Cleared
ClearedGetinge 633HC Steam Sterilizer Air Glide System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getinge Sourcing, LLC · PEC Sterilizer Automated Loading System
Cleared on May 2, 2013 as substantially equivalent to K070657 (Getinge Sourcing, LLC, 2007) after a 435-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- May 2, 2013
- Review
- 435 days
- Class
- Class II
- Product code
- PEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820783 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 4 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 3 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 2 generations backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- 1 generation backK070657 Getinge 633HC Series Vacuum/Gravity Steam SterilizerGetinge Sourcing, LLC · 2007
- This deviceK120532 Getinge 633HC Steam Sterilizer Air Glide SystemGetinge Sourcing, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −4 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −3 | 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 | — |
| −1 | K070657 | Getinge 633HC Series Vacuum/Gravity Steam Sterilizer | Getinge Sourcing, LLC | 2007 | — |
| 0 (this device) | K120532 | Getinge 633HC Steam Sterilizer Air Glide System | 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 PEC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K070657 | Getinge 633HC Series Vacuum/Gravity Steam SterilizerSummary page 1…mmon Name: Steam Sterilizer Device Classification: PEC Class 11,as listed per 21 CFR 880.6880 Predicate Device: K070657, Getinge 633HC Series Vacuum/Gravity Steam Sterilizer. S.E. Date 4/6/07 Description of Device: The… | 2007 |
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 5.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K070657.
How does its category compare?
All PEC devicesPEC Sterilizer Automated Loading System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PEC
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PEC
Too few PEC 510(k)s in any year since 2007 to give a median.
Recalls per year · PEC
No recall names PEC since 2007.
Adverse event reports per year · PEC
1in 2021
MAUDE reports naming product code PEC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120532: Getinge 633HC Steam Sterilizer Air Glide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120532
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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