510(k) · Cleared
Cleared3M™ Attest™ Steam Chemical Integrators
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 Nov 22, 2019 as substantially equivalent to K101249 (3M Company, 2010) after a 198-day review. Its family tree reaches back 2 generations to 1977. 3 later devices descend from it.
- Decided
- Nov 22, 2019
- Review
- 198 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K771080 (1977). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK771080 Steam Sterilization IndicatorInfo-Chem · 1977
- 1 generation backK101249 Sterigage Model 1243RA, 1243RB, 1243RE3M Company · 2010
- This deviceK191236 3M™ Attest™ Steam Chemical Integrators3M Company · 2019
- Descendant · cites it directly · 2 of its ownK193254 3M Attest Steam Chemical Integrator3M Company · 2019
- Descendant · 2 generations on · 1 of its ownK220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK261992 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K1932543M Attest Steam Chemical Integrator3M Company · 2019 · cites it directly2descendants
- K2209423M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022 · 2 generations on1descendant
- K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771080 | Steam Sterilization Indicator | Info-Chem | 1977 | — |
| −1 | K101249 | Sterigage Model 1243RA, 1243RB, 1243RE | 3M Company | 2010 | — |
| 0 (this device) | K191236 | 3M™ Attest™ Steam Chemical Integrators | 3M Company | 2019 | — |
| +1 | K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019 | — |
| +2 | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | 2022 | 2 |
| +3 | K261992 | 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K101249 | Sterigage Model 1243RA, 1243RB, 1243RESummary page 5…fication: Class II, 21 CFR § 880.2800(b) Product Code: JOJ 2. Predicate Device: 3M™ Comply™ SteriGage™ Chemical Integrator for Steam (K101249) 3. Description of Device: 3M™ Attest™ Steam Chemical Integrators are chemical indicators consisting of a paper wi… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193254 | 3M Attest Steam Chemical Integrator | 2019 | 2 |
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 42 years and passes through 2 companies; a new generation was cleared every 33.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K193254 (3M Company, 2019) has gone furthest, with 2 descendants of its own.
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 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Cycle Type Temperature Exposure Time Gravity 250°F/121°C 30 minutes Gravity 270°F/132°C 3, 4…
Read the full statement (132 words)
The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Cycle Type Temperature Exposure Time
Gravity 250°F/121°C 30 minutes
Gravity 270°F/132°C 3, 4, 10, 15, 25 minutes
Gravity 275°F/135°C 3, 10 minutes
Dynamic Air Removal 250°F/121°C 30 minutes
Dynamic Air Removal 270°F/132°C 4, 10 minutes
Dynamic Air Removal 273°F/134°C 3, 4 minutes
Dynamic Air Removal 275°F/135°C 3 minutes
Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:
250°F/ 121°C: 16.5 minutes
270°F/ 132°C: 2.0 minutes
273°F/ 134°C: 1.4 minutes
275°F/ 135°C: 1.2 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191236: 3M™ Attest™ Steam Chemical Integrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191236
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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