510(k) Report

510(k) · Cleared

Cleared

Castle Series 200 Steam Sterilizer (Powerclave)

K973225510(k) TraditionalCleared Feb 10, 1998167-day reviewClass II21 CFR 880.6880

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

K820783 · Castle Microcomputer Sterilizer Control · Sybron Corp. · 198219801985199019952000
  1. Root · 1 generation backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
  2. This deviceK973225 Castle Series 200 Steam Sterilizer (Powerclave)Getinge/Castle, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K820783Castle Microcomputer Sterilizer ControlSybron Corp.1982—
0 (this device)K973225Castle Series 200 Steam Sterilizer (Powerclave)Getinge/Castle, Inc.1998—
FIG. 1 — Lineage of K973225, 1982–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K820783Castle Microcomputer Sterilizer Control
Summary 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…
Sybron Corp.1982—

Also cleared against K820783: 2 other devices →

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 devices

FLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLE

4in 2025

2007: 52008: 12009: 82010: 22011: 52012: 52013: 52014: 22015: 32016: 12017: 32018: 82019: 52020: 22021: 52022: 102023: 72024: 22025: 42026 (partial year): 3
2007high 10 (2022) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLE

184in 2025

2007: 67 days median2009: 109 days median2011: 141 days median2012: 111 days median2013: 241 days median2015: 302 days median2017: 233 days median2018: 146 days median2019: 192 days median2021: 147 days median2022: 133 days median2023: 88 days median2025: 184 days median2026 (partial year): 85 days median
2007high 302 (2015) · low 67 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLE

1in 2021

2007: 12008: 12011: 12012: 12013: 22015: 12018: 12019: 22021: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLE

71in 2025

2007: 192008: 212009: 192010: 202011: 632012: 692013: 1122014: 1132015: 682016: 762017: 632018: 902019: 912020: 872021: 812022: 702023: 662024: 642025: 71
2007high 113 (2014) · low 19 (2007)2025

MAUDE reports naming product code FLE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007567119
20081—121
20098109019
20102—020
20115141163
20125111169
201352412112
20142—0113
20153302168
20161—076
20173233063
20188146190
20195192291
20202—087
20215147181
202210133070
2023788066
20242—064
20254184071
20263851—

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.

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