510(k) · Cleared
ClearedChemical Indicator for Steam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
True Indicating, LLC · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Dec 2, 2022 as substantially equivalent to K181788 (Kem Medical Products Corp., 2019) after a 260-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 2, 2022
- Review
- 260 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932129 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 2 generations backK101528 3M Comply Lead Free Process Indicators for Steam3M Company · 2010 · Recalled
- 1 generation backK181788 Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corp. · 2019
- This deviceK220778 Chemical Indicator for SteamTrue Indicating, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −2 | K101528 | 3M Comply Lead Free Process Indicators for Steam | 3M Company | 2010 | 1 |
| −1 | K181788 | Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | 2019 | — |
| 0 (this device) | K220778 | Chemical Indicator for Steam | True Indicating, LLC | 2022 | — |
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 JOJ? 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 JOJ device
- #1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 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 |
|---|---|---|---|
| * | K181788 | Lead-free Chemical Indicators for Steam SterilizationSummary page 4…Class II Medical Device, FDA Product Code JOJ, General Hospital Predicate Devices: (Legally Marketed) Lead-free Chemical Indicators for Steam Sterilization (K181788) Description of Device: The True Indicating Lead-Free Chemical Indicator for Steam product codes CSYN-US… | 2019 |
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 28 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 2025
MAUDE reports naming product code JOJ, 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 | 8 | 140 | 0 | 1 |
| 2008 | 9 | 57 | 2 | 1 |
| 2009 | 7 | 188 | 2 | 9 |
| 2010 | 6 | 115 | 0 | 3 |
| 2011 | 13 | 151 | 2 | 1 |
| 2012 | 7 | 224 | 0 | 8 |
| 2013 | 6 | 212 | 0 | 6 |
| 2014 | 6 | 198 | 0 | 11 |
| 2015 | 8 | 188 | 0 | 7 |
| 2016 | 4 | 150 | 0 | 11 |
| 2017 | 7 | 172 | 0 | 35 |
| 2018 | 5 | 150 | 0 | 12 |
| 2019 | 12 | 38 | 0 | 8 |
| 2020 | 7 | 108 | 0 | 6 |
| 2021 | 4 | 87 | 1 | 29 |
| 2022 | 8 | 90 | 0 | 23 |
| 2023 | 4 | 53 | 1 | 39 |
| 2024 | 12 | 71 | 0 | 25 |
| 2025 | 6 | 90 | 0 | 12 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to…
Read the full statement (130 words)
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods.
The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:
Gravity: 121°C/250 F- 30 minutes (wrapped/porous)
Pre-vacuum: 132°C/270 F- 3 minutes (unwrapped/nonporous)
Pre-vacuum: 132°C/270 F- 4 minutes (wrapped/porous)
Pre-vacuum: 134°C/273 F- 4 minutes (wrapped/porous)
Pre-vacuum: 135°C/275 F- 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220778: Chemical Indicator for Steam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220778
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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