510(k) · Cleared
ClearedSpsmedical Sporview PA Culture Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spsmedical Supply Corp. · MRB Indicator, Biological, Liquid Chemical Sterilization Process
Cleared on Jan 13, 2005 as substantially equivalent to K020205 (Getinge/Castle, Inc., 2002) after a 62-day review. Its family tree reaches back 3 generations to 1980. 1 later device descends from it.
- Decided
- Jan 13, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- MRB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K792649 (1980). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK043135 Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2005
- Descendant · cites it directly · 0 of its ownK081879 Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081879Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008 · cites it directly0descendants
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) | K043135 | Spsmedical Sporview PA Culture Set | Spsmedical Supply Corp. | 2005 | — |
| +1 | K081879 | Spsmedical Sporview PA Culture Set | Spsmedical Supply Corp. | 2008 | — |
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 |
|---|---|---|
| 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 MRB? 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 |
|---|---|---|---|
| * | K020205 | Castle Peracetic Acid Biological Indicator KitSummary page 1…Classification: Sterilization Process Indicator - 21 CFR 880.2800 (a) Class I1 Predicate Device: Castle® SPOR-TEST PA Biological Indicator Kit (K020205) Device Description: SporView® PA Culture Set is intended to monitor the STERIS System I1 peracetic acid sterilization process… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081879 | Spsmedical Sporview PA Culture Set | 2008 | 0 |
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.
- Of its descendants, K081879 (Spsmedical Supply Corp., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020205.
How does its category compare?
All MRB devicesMRB Indicator, Biological, Liquid Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRB
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MRB
Too few MRB 510(k)s in any year since 2007 to give a median.
Recalls per year · MRB
No recall names MRB since 2007.
Adverse event reports per year · MRB
1in 2018
MAUDE reports naming product code MRB, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 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 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 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 SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043135: Spsmedical Sporview PA Culture Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043135
Report an extraction error
Are you the manufacturer?
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