510(k) · Cleared
ClearedLead-free Chemical Indicators for Steam Sterilization
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kem Medical Products Corp. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Mar 1, 2019 as substantially equivalent to K101528 (3M Company, 2010) after a 239-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Mar 1, 2019
- Review
- 239 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932129 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 1 generation backK101528 3M Comply Lead Free Process Indicators for Steam3M Company · 2010 · Recalled
- This deviceK181788 Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corp. · 2019
- Descendant · cites it directly · 0 of its ownK220778 Chemical Indicator for SteamTrue Indicating, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K220778Chemical Indicator for SteamTrue Indicating, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −1 | K101528 | 3M Comply Lead Free Process Indicators for Steam | 3M Company | 2010 | 1 |
| 0 (this device) | K181788 | Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | 2019 | — |
| +1 | K220778 | Chemical Indicator for Steam | True Indicating, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K101528 | 3M Comply Lead Free Process Indicators for SteamSummary page 4…ication Name: Indicator, Physical/Chemical Sterilization Process (21 CFR800.2800, Product Code JOJ) Predicate Device: 3M Comply Lead Free Process Indicators for Steam, K101528 **There have not been any prior submissions for this device.**… | 2010 |
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 |
|---|---|---|---|
| K220778 | Chemical Indicator for Steam | 2022 | 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 2 companies; a new generation was cleared every 16.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K220778 (True Indicating, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101528.
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. 2019, 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 Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below: *Gravity: 121 C/250 F - 30 minutes…
Read the full statement (149 words)
The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below:
*Gravity: 121 C/250 F - 30 minutes (wrapped/porous)
*Gravity: 132 C/270 F - 3 minutes (unwrapped/nonporous)
*Gravity: 132 C/270 F - 15 minutes (wrapped/porous)
*Gravity: 135 C/275 F - 3 minutes (unwrapped/nonporous)
*Gravity: 135 C/275 F - 10 minutes (wrapped/porous or unwrapped/nonporous, mixed load)
*Vacuum assisted (prevacuum): 132 C/270 F - 3 minutes (unwrapped/nonporous)
*Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes (wrapped/porous)
*Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes (wrapped/porous)
*Vacuum assisted (prevacuum): 135 C/275 F - 3 minutes (wrapped/porous or unwrapped/nonporous, mixed load)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181788: Lead-free Chemical Indicators for Steam Sterilization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181788
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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