510(k) · Cleared
Recalled · Class III · 20223M Comply Lead Free Process Indicators for Steam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Oct 1, 2010 as substantially equivalent to K932129 (3M Company, 1994) after a 121-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 1, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932129 (1994). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK932129 3M Autoclave Tapes3M Company · 1994
- This deviceK101528 3M Comply Lead Free Process Indicators for Steam3M Company · 2010
- Descendant · cites it directly · 1 of its ownK220564 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free…3M Company · 2022
- Descendant · cites it directly · 1 of its ownK181788 Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corp. · 2019
- Descendant · 2 generations on · 0 of its ownK251991 SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241836 Kem Medical Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK220778 Chemical Indicator for SteamTrue Indicating, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K2205643M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape…3M Company · 2022 · cites it directly1descendant
- K181788Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corp. · 2019 · cites it directly1descendant
- K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025 · 2 generations on0descendants
- K241836Kem Medical Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corporation · 2024 · cites it directly0descendants
- K220778Chemical Indicator for SteamTrue Indicating, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| 0 (this device) | K101528 | 3M Comply Lead Free Process Indicators for Steam | 3M Company | 2010 | — |
| +1 | K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam… | 3M Company | 2022 | — |
| +1 | K181788 | Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | 2019 | — |
| +2 | K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)… | Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. | 2025 | — |
| +1 | K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation | 2024 | — |
| +2 | K220778 | Chemical Indicator for Steam | True Indicating, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K932129 | 3M Autoclave TapesSummary page 2…bmission is to: * Replace the lead ink in the current 3MTM CoMplyTm Autoclave Tape with Lead Free Ink. The current Comply Autoclave Tape was cleared under K932 129 * Apply the Lead Free Ink to cardstock as a new 3MTM CoMplyTm Record Card * Replace the lead ink in the process indic… | 1994 |
| † | K093199 | 3M Comply Bowie- Dick Type Lead Free Test Pack | 2009 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1794-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2010, 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 3M Comply Lead Free Process Indicators for Steam are designed 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. 3M Comply Lead Free Process Indicators for Steam include: * Comply 68200 Lead Free Record Card * Comply 1322 Lead Free Indicator Tape * Lead Free Test Pack Labels to be used on test packs including the following - o Comply 41380…
Read the full statement (217 words)
The 3M Comply Lead Free Process Indicators for Steam are designed 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.
3M Comply Lead Free Process Indicators for Steam include:
* Comply 68200 Lead Free Record Card
* Comply 1322 Lead Free Indicator Tape
* Lead Free Test Pack Labels to be used on test packs including the following -
o Comply 41380 Steam-Plus Test Pack
o Comply 41360 Steam Test Pack
o Attest 1276 Steam Test Pack
o Attest 1296 Steam Test Pack
o Attest 41382 Steam-Plus Test Pack
o Comply 1233LF, 00132LF, 00135LF Bowie Dick Test Packs
Use the 3M Comply Lead Free Process Indicators for Steam in steam sterilization processes described below.
Cycle Type — Temperature — Exposure Time
Gravity — 250 °F/121 °C — > 30 minutes (wrapped)
Gravity — 270 °F/132 °C — > 3 minutes (unwrapped); > 15 minutes (wrapped)
Gravity — 275 °F/135 °C — > 3 minutes (unwrapped); > 11 minutes (wrapped)
Vacuum-assisted (prevacuum) — 270 °F/132 °C — > 3 minutes (unwrapped); > 4 minutes (wrapped)
Vacuum-assisted (prevacuum) — 273 °F/134 °C — > 3.5 minutes (unwrapped); 4 minutes (wrapped)
Vacuum-assisted (prevacuum) — 275 °F/135 °C — > 3 minutes (wrapped or unwrapped)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101528 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101528: 3M Comply Lead Free Process Indicators for Steam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101528
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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