510(k) · Cleared
Recalled · Class II · 20233M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
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 Jun 24, 2022 as substantially equivalent to K193254 (3M Company, 2019) after an 85-day review. Its family tree reaches back 4 generations to 1977. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 24, 2022
- Review
- 85 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K771080 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK771080 Steam Sterilization IndicatorInfo-Chem · 1977
- 3 generations backK101249 Sterigage Model 1243RA, 1243RB, 1243RE3M Company · 2010
- 2 generations backK191236 3M™ Attest™ Steam Chemical Integrators3M Company · 2019
- 1 generation backK193254 3M Attest Steam Chemical Integrator3M Company · 2019
- This deviceK220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022
- Descendant · cites it directly · 0 of its ownK261992 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771080 | Steam Sterilization Indicator | Info-Chem | 1977 | — |
| −3 | K101249 | Sterigage Model 1243RA, 1243RB, 1243RE | 3M Company | 2010 | — |
| −2 | K191236 | 3M™ Attest™ Steam Chemical Integrators | 3M Company | 2019 | — |
| −1 | K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019 | — |
| 0 (this device) | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K193254 | 3M Attest Steam Chemical IntegratorSummary page 6…ical/chemical sterilization process indicator Device Classification: Class II, 21 CFR § 880.2800(b) Product Code: JOJ 2. Predicate Device: K193254, 3M™ Attest™ Steam Chemical Integrators 3. Description of Device: 3M™ Attest™ Steam Chemical Integrators are chemical indica… | 2019 |
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 |
|---|---|---|---|
| K261992 | 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2023 | Class II | Z-1610-2023 | Process control | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle. |
| Apr 6, 2023 | Class II | Z-1609-2023 | Process control | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 45 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K261992 (Solventum US, LLC, 2026) has gone furthest, with 0 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. 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 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…
Read the full statement (183 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 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 275°F/135°C
16.5 Minutes 2.0 Minutes 1.4 Minutes 1.2 Minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220942: 3M Attest Steam Chemical Integrators (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/K220942
Report an extraction error
Are you the manufacturer?
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