510(k) · Cleared
ClearedSterigage Model 1243RA, 1243RB, 1243RE
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 Sep 8, 2010 as substantially equivalent to K771080 (Info-Chem, 1977) after a 127-day review. Its family tree reaches back 1 generation to 1977. 4 later devices descend from it.
- Decided
- Sep 8, 2010
- Review
- 127 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771080 (1977). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK771080 Steam Sterilization IndicatorInfo-Chem · 1977
- This deviceK101249 Sterigage Model 1243RA, 1243RB, 1243RE3M Company · 2010
- Descendant · cites it directly · 3 of its ownK191236 3M™ Attest™ Steam Chemical Integrators3M Company · 2019
- Descendant · 2 generations on · 2 of its ownK193254 3M Attest Steam Chemical Integrator3M Company · 2019
- Descendant · 3 generations on · 1 of its ownK220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022 · Recalled
- Descendant · 4 generations on · 0 of its ownK261992 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026
Most influential descendants
Showing 4 of 4 · See all- K1912363M™ Attest™ Steam Chemical Integrators3M Company · 2019 · cites it directly3descendants
- K1932543M Attest Steam Chemical Integrator3M Company · 2019 · 2 generations on2descendants
- K2209423M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022 · 3 generations on1descendant
- K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771080 | Steam Sterilization Indicator | Info-Chem | 1977 | — |
| 0 (this device) | K101249 | Sterigage Model 1243RA, 1243RB, 1243RE | 3M Company | 2010 | — |
| +1 | K191236 | 3M™ Attest™ Steam Chemical Integrators | 3M Company | 2019 | — |
| +2 | K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019 | — |
| +3 | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | 2022 | 2 |
| +4 | 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 | 2 | 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 |
|---|---|---|---|
| * | K771080 | Steam Sterilization IndicatorSummary page 3…SteriGageTm Chemical Integrator for Steam is substantially equival ent to the predicate device, the current 3M~m ComplyTm SteriGageTm Chemical Integrator, cleared under K771080 in terms of design, intended use, indications for use, composition, physical properties and technological characteristics. The on… | 1977 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191236 | 3M™ Attest™ Steam Chemical Integrators | 2019 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K191236 (3M Company, 2019) has gone furthest, with 3 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. 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 SteriGage 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles. Cycle Type: Gravity; Temperature: 250.0°F/121°C; Exposure Time: ≥30 minutes Cycle Type: Gravity; Temperature: 270°F/132°C; Exposure Time: ≥3 minutes Cycle Type: Vacuum-assisted (prevacuum); Temperature: 270°F/132°C; Exposure Time: >4 minutes (wrapped), >3 minutes (unwrapped) Cycle Type: Vacuum-assisted…
Read the full statement (112 words)
The 3M Comply SteriGage 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles.
Cycle Type: Gravity; Temperature: 250.0°F/121°C; Exposure Time: ≥30 minutes
Cycle Type: Gravity; Temperature: 270°F/132°C; Exposure Time: ≥3 minutes
Cycle Type: Vacuum-assisted (prevacuum); Temperature: 270°F/132°C; Exposure Time: >4 minutes (wrapped), >3 minutes (unwrapped)
Cycle Type: Vacuum-assisted (prevacuum); Temperature: 273°F/134°C; Exposure Time: ≥4 minutes (wrapped), ≥3.5 minutes (unwrapped)
Cycle Type: Vacuum-assisted (prevacuum); Temperature: 275°F/135°C; Exposure Time: ≥3 minutes
The Minimum Stated Values for SteriGage as determined using a resistometer are shown below.
Minimum Stated Values for SteriGage
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): 1.1 minute
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101249: Sterigage Model 1243RA, 1243RB, 1243RE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101249
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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