510(k) · Cleared
ClearedSpor-Test PA Biological Indicator Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getinge USA, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Apr 7, 2005 as substantially equivalent to K020205 (Getinge/Castle, Inc., 2002) after a 23-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Apr 7, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K792649 (1980). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK792649 Unispore-Biological IndicatorsCastle Co. · 1980
- 2 generations backK960777 MDT Unispore and Spor-Test BiologicalindicatorMdt Corp., Inc. · 1996
- 1 generation backK020205 Castle Peracetic Acid Biological Indicator KitGetinge/Castle, Inc. · 2002
- This deviceK050664 Spor-Test PA Biological Indicator KitGetinge USA, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792649 | Unispore-Biological Indicators | Castle Co. | 1980 | — |
| −2 | K960777 | MDT Unispore and Spor-Test Biologicalindicator | Mdt Corp., Inc. | 1996 | — |
| −1 | K020205 | Castle Peracetic Acid Biological Indicator Kit | Getinge/Castle, Inc. | 2002 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K020205 | Castle Peracetic Acid Biological Indicator KitSummary page 1…POR-TEST PA Biological Indicator Kit's manufacturing material, manufacturing Kit (K020205). The storage conditions are the same as the Castle SPOR-TEST PA Biological Indicator… | 2002 |
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 25 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K020205.
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 SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System I liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated.
SPOR-TEST PA Biological Indicators are qualified using Getinge Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the 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/K050664 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050664: Spor-Test PA Biological Indicator Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050664
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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