510(k) · Cleared
ClearedSelf-Contained Biological Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
True Indicating, LLC · FRC Indicator, Biological Sterilization Process
Cleared on Dec 28, 2020 as substantially equivalent to K122024 (Spsmedical Supply Corp., 2013) after a 259-day review. Its family tree reaches back 5 generations to 1980.
- Decided
- Dec 28, 2020
- Review
- 259 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801109 (1980). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
- 4 generations backK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
- 3 generations backK070595 Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007
- 2 generations backK111515 Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012
- 1 generation backK122024 Spsmedical Sporview 10 Steam Self Contained Biological IndicatorSpsmedical Supply Corp. · 2013
- This deviceK200970 Self-Contained Biological IndicatorTrue Indicating, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −4 | K963841 | Eztest | Sgm Biotech, Inc. | 1997 | 1 |
| −3 | K070595 | Sporview Steam Self-Contained Biological Indicator | Spsmedical Supply Corp. | 2007 | — |
| −2 | K111515 | Spsmedical Sporview Steam BI | Spsmedical Supply Corp. | 2012 | — |
| −1 | K122024 | Spsmedical Sporview 10 Steam Self Contained Biological Indicator | Spsmedical Supply Corp. | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K122024 | Spsmedical Sporview 10 Steam Self Contained Biological IndicatorSummary page 4…0, Class II Medical Device, FDA Product Code FRC, General Hospital Predicate Devices: SporView® 10 Steam Self Contained Biological Indicator (K122024) (Legally Marketed) Device Description: The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 -… | 2013 |
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 40 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles:
121°C, 30 minutes (Gravity)
132°C, 4 minutes (Pre-Vacuum)
135°C, 3 minutes (Pre-Vacuum)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200970: 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/K200970
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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