510(k) · Cleared
ClearedInstant 20s Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
True Indicating, LLC · MTC Indicator, Chemical, Enzymatic, Sterilization Process
Cleared on Dec 14, 2021 as substantially equivalent to K962649 (North American Science Assoc., Inc., 1997) after a 298-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 14, 2021
- Review
- 298 days
- Class
- Class II
- Product code
- MTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962649 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK962649 Sportrol Rapid Sterility IndicatorNorth American Science Assoc., Inc. · 1997
- This deviceK210481 Instant 20s IndicatorTrue Indicating, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962649 | Sportrol Rapid Sterility Indicator | North American Science Assoc., Inc. | 1997 | — |
| 0 (this device) | K210481 | Instant 20s Indicator | True Indicating, LLC | 2021 | — |
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 MTC? 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 |
|---|---|---|---|
| * | K962649 | Sportrol Rapid Sterility IndicatorSummary page 4…Classification: Class II Medical Device, FDA Product Code MTC, General Hospital Predicate Devices: (Legally Marketed) Sportrol Rapid Sterility Indicator, K962649 Description of Device: The True Indicating Instant 20s Indicator consists of a polycarbonate vial, polyp… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MTC devicesMTC Indicator, Chemical, Enzymatic, Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MTC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MTC
Too few MTC 510(k)s in any year since 2007 to give a median.
Recalls per year · MTC
No recall names MTC since 2007.
Adverse event reports per year · MTC
No MAUDE report names MTC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 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 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 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 True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring
saturated steam sterilization processes operating at:
121 0 C, 30 minutes (Gravity)
132 0 C, 4 minutes (Pre-Vacuum)
135 0 C, 3 minutes (Pre-Vacuum)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210481 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210481: Instant 20s Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210481
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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