510(k) · Cleared
ClearedCastle Series 200 Steam Sterilizer (Powerclave)
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 Feb 10, 1998 as substantially equivalent to K820783 (Sybron Corp., 1982) after a 167-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Feb 10, 1998
- Review
- 167 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K820783 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- This deviceK973225 Castle Series 200 Steam Sterilizer (Powerclave)Getinge/Castle, Inc. · 1998
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) | K973225 | Castle Series 200 Steam Sterilizer (Powerclave) | Getinge/Castle, Inc. | 1998 | — |
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 2…eam Sterilizer (per 21 CFR 880.6880) Per 21CFR 807.92(a)(3) We believe this product to be substantially equivalent to our Castle Microcomputer Controls and Sterilizers K820783. Per 21CFR 807.92(a)(4), (5) & (6) The Castle Series 200 Sterilizers (Powerclave) is a control system upgrade of an existing mi… | 1982 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K820783.
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?
Indoor Use Only Model 222: The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped hard goods such as instruments and…
Read the full statement (561 words)
Indoor Use Only
Model 222:
The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies.
Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens.
Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard
goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped
hard goods such as instruments and utensils. Steam sterilization by the unwrapped (flash) method is
employed when time does not permit the use of the preferable, wrapped sterilization procedure.
Implantables should never be sterilized by the unwrapped (flash) method. All cycles employ gravity or
downward displacement with positive pulsing conditioning for dynamic air removal. Processing
temperatures range from 250°F to 275°F (121°C to 135°C)
The cycles to be cleared for this model (Model 222) are:
Exposure Dry
Cycle Name Type Temp Minutes Minutes ~-
P1 GRAVWRAP 1 Gravity 250°F 250°F 30 30
P2 GRAV WRAP 2 Gravity 275°F 275°F 10 30
P3 FLASH3+ Gravity 3 Minutes 275°F 3 0
P4 FLASH 10+ Gravity 10 Minutes 275°F 10 0
Model 233:
The Castle Model 233 Vacuum Steam Sterilizer is intended for steam sterilization of hospital
supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens.
Wrapped-goods (Hi Vac) cycles are provided for processing wrapped linen packs, as well as
wrapped hard goods such as instruments and utensils. A gravity cycle is provided for processing wrapped
dry goods and/or hard goods. Additionally, a Vacuum Leak Test cycle, not intended for sterilization, and an
Air-Removal-Test-Pack (Bowie-Dick) cycle, not intended for sterilization is provided. The wrapped-goods
(Hi Vac) cycles employ vacuum-and-positive pulsing to condition a load before processing at the selected
exposure temperature. The gravity cycle employs the gravity, or downward displacement method of air
removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C).
The cycles to be cleared for this model (Model 233) are:
Exposure Dry
Cycle Name Type Temp Minutes Minutes
P1 PREVACONE Prevac275°F 275°F 3 16
P2 PREVACTWO Prevac275°F 275°F 3 3
P3 GRAVITY WRAP ' Gravity 250°F ~'250°F " ~7"30 "~~~ 730 i
P5 B-DTEST Air Removal 273°F 3.5 0}
P6 VACLEAKTST Vacuumleak 268°F 3 15(dry)+5(dwell)+15(test)
Model 223:
The Castle Model 223 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies.
Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens.
Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard
goods such as instruments and utensils. The cycles employ gravity or downward displacement with positive
pulsing conditioning for dynamic air removal. Processing temperatures for wrapped goods cycles range
from 250°F to 275°F (121°C to 135°C).
The cycles to be cleared for this model (Model 223) are:
Exposure Dry
Cycle Name Type Temp Minutes Minutes
P1 GRAV WRAP 1 Gravity 250°F 250°F 30 30
P2 GRAV WRAP 2 Gravity 275°F 275°F 10 30
All Models:
Castle Series 200 Steam Sterilizers are programmed with factory recommended sterilization
parameters (cycle settings) which have been verified and validated for efficacy. By using a supervisory
password, the controls allow for flexibility in selecting exposure temperature, exposure time, and drying
time. It is possible, with that password, to select cycle settings that will not necessarily achieve the desired
sterility assurance level. Users with password access are responsible for the efficacy of any cycle settings
other than the factory recommended settings.
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/K973225 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973225: Castle Series 200 Steam Sterilizer (Powerclave).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973225
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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