510(k) · Cleared
ClearedSporview Steam Self-Contained Biological Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spsmedical Supply Corp. · FRC Indicator, Biological Sterilization Process
Cleared on May 24, 2007 as substantially equivalent to K963841 (Sgm Biotech, Inc., 1997) after an 83-day review. Its family tree reaches back 2 generations to 1980. 3 later devices descend from it.
- Decided
- May 24, 2007
- Review
- 83 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801109 (1980). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
- 1 generation backK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
- This deviceK070595 Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007
- Descendant · cites it directly · 2 of its ownK111515 Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012
- Descendant · cites it directly · 1 of its ownK122024 Spsmedical Sporview 10 Steam Self Contained Biological IndicatorSpsmedical Supply Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK200970 Self-Contained Biological IndicatorTrue Indicating, LLC · 2020
Most influential descendants
Showing 3 of 3 · See all- K111515Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012 · cites it directly2descendants
- K122024Spsmedical Sporview 10 Steam Self Contained Biological IndicatorSpsmedical Supply Corp. · 2013 · cites it directly1descendant
- K200970Self-Contained Biological IndicatorTrue Indicating, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −1 | K963841 | Eztest | Sgm Biotech, Inc. | 1997 | 1 |
| 0 (this device) | K070595 | Sporview Steam Self-Contained Biological Indicator | Spsmedical Supply Corp. | 2007 | — |
| +1 | K111515 | Spsmedical Sporview Steam BI | Spsmedical Supply Corp. | 2012 | — |
| +1 | K122024 | Spsmedical Sporview 10 Steam Self Contained Biological Indicator | Spsmedical Supply Corp. | 2013 | — |
| +2 | K200970 | Self-Contained Biological Indicator | True Indicating, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K963841 | EztestSummary page 1…cal Indicator Device Classification: Class H,Regulation Number 880.2800 Product Code: FRC Predicate Device: SGM EZTest® - Steam (K963841) Device Description: The SPSmedical SporView® biological indicator consists of a self-contained unit that includ… | 1997 |
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 27 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K111515 (Spsmedical Supply Corp., 2012) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K963841.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilusbacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121'C and 132'C gravity displacement, 132'C flash gravity displacement and 121 'C - 134'C prevacuum cycles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070595: Sporview Steam Self-Contained Biological Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070595
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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