510(k) · Cleared
Cleared3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solventum US, LLC · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Sep 25, 2026 as substantially equivalent to K220942 (3M Company, 2022) after a 102-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Sep 25, 2026
- Review
- 102 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K771080 (1977). No later device cites it as a predicate yet.
- Root · 5 generations backK771080 Steam Sterilization IndicatorInfo-Chem · 1977
- 4 generations backK101249 Sterigage Model 1243RA, 1243RB, 1243RE3M Company · 2010
- 3 generations backK191236 3M™ Attest™ Steam Chemical Integrators3M Company · 2019
- 2 generations backK193254 3M Attest Steam Chemical Integrator3M Company · 2019
- 1 generation backK220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022 · Recalled
- This deviceK261992 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771080 | Steam Sterilization Indicator | Info-Chem | 1977 | — |
| −4 | K101249 | Sterigage Model 1243RA, 1243RB, 1243RE | 3M Company | 2010 | — |
| −3 | K191236 | 3M™ Attest™ Steam Chemical Integrators | 3M Company | 2019 | — |
| −2 | K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019 | — |
| −1 | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | 2022 | 2 |
| 0 (this device) | K261992 | 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | 2026 | — |
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 K240760 CELERITY HP Indicator Tapescore 12.6 · 9 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 |
|---|---|---|---|
| * | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)Summary page 7…al/chemical sterilization process indicator Class II, Device Classification: 21 CFR § 880.2800(b) Product Code: JOJ 2. Predicate Device: K220942, 3M™ Attest™ Steam Chemical Integrator 3. Description of Device: 3M™ Attest™ Steam Chemical Integrators are chemical indicat… | 2022 |
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 49 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 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. 2026, 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 critical 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…
Read the full statement (184 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
critical 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 minutes
Gravity 270°F/132°C 4 minutes
Gravity 270°F/132°C 10 minutes
Gravity 270°F/132°C 15 minutes
Gravity 270°F/132°C 25 minutes
Gravity 275°F/135°C 3 minutes
Gravity 275°F/135°C 10 minutes
Dynamic Air Removal 250°F/121°C 30 minutes
Dynamic Air Removal 270°F/132°C 4 minutes
Dynamic Air Removal 270°F/132°C 5 minutes
Dynamic Air Removal 270°F/132°C 6 minutes
Dynamic Air Removal 270°F/132°C 7 minutes
Dynamic Air Removal 270°F/132°C 8 minutes
Dynamic Air Removal 270°F/132°C 9 minutes
Dynamic Air Removal 270°F/132°C 10 minutes
Dynamic Air Removal 273°F/134°C 3 minutes
Dynamic Air Removal 273°F/134°C 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 270°F/132°C 273°F/134°C
16.5 Minutes 2.0 Minutes 1.4 Minutes
275°F/135°C
1.2 Minutes
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261992: 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261992
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026