510(k) · Cleared
ClearedCastle Peracetic Acid Biological Indicator Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getinge/Castle, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Jun 24, 2002 as substantially equivalent to K960777 (Mdt Corp., Inc., 1996) after a 153-day review. Its family tree reaches back 2 generations to 1980. 3 later devices descend from it.
- Decided
- Jun 24, 2002
- Review
- 153 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K792649 (1980). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK792649 Unispore-Biological IndicatorsCastle Co. · 1980
- 1 generation backK960777 MDT Unispore and Spor-Test BiologicalindicatorMdt Corp., Inc. · 1996
- This deviceK020205 Castle Peracetic Acid Biological Indicator KitGetinge/Castle, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK043135 Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK081879 Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008
- Descendant · cites it directly · 0 of its ownK050664 Spor-Test PA Biological Indicator KitGetinge USA, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K043135Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2005 · cites it directly1descendant
- K081879Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008 · 2 generations on0descendants
- K050664Spor-Test PA Biological Indicator KitGetinge USA, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792649 | Unispore-Biological Indicators | Castle Co. | 1980 | — |
| −1 | K960777 | MDT Unispore and Spor-Test Biologicalindicator | Mdt Corp., Inc. | 1996 | — |
| 0 (this device) | K020205 | Castle Peracetic Acid Biological Indicator Kit | Getinge/Castle, Inc. | 2002 | — |
| +1 | K043135 | Spsmedical Sporview PA Culture Set | Spsmedical Supply Corp. | 2005 | — |
| +2 | K081879 | Spsmedical Sporview PA Culture Set | Spsmedical Supply Corp. | 2008 | — |
| +1 | K050664 | Spor-Test PA Biological Indicator Kit | Getinge USA, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 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 FRC? 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 FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K960570 | Steris Process Biological Indicator Kit Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…rilization Process Indicator - 21 CFR 880.2800 (a) Class I I Predicate Devices: SterisB Process Biological Indicator Kit (K960570) MDT UnisporeB and Spor-Test Biological Indicator (K960777) Device Description: The Castle@ SP… | |
| * | K960777 | MDT Unispore and Spor-Test BiologicalindicatorSummary page 1…I Predicate Devices: SterisB Process Biological Indicator Kit (K960570) MDT UnisporeB and Spor-Test Biological Indicator (K960777) Device Description: The Castle@ SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the SterisB System 1… | 1996 |
What descends from it? (3)
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 22 years and passes through 3 companies; a new generation was cleared every 16.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K043135 (Spsmedical Supply Corp., 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, 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 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
The Castle SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated.
Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020205: Castle Peracetic Acid Biological Indicator Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020205
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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