510(k) · Cleared
Cleared3M Comply Hydrogen Peroxide Chemical Indicator 1248
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 Dec 11, 2020 as substantially equivalent to K192937 (3M Company, 2019) after a 17-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Dec 11, 2020
- Review
- 17 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921910 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 5 generations backK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- 4 generations backK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- 3 generations backK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- 2 generations backK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- 1 generation backK192937 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- This deviceK203458 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2020
- Descendant · cites it directly · 0 of its ownK222508 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 12483M Company · 2022
Most influential descendants
Showing 1 of 1 · See all- K2225083M™ Comply™ Hydrogen Peroxide Chemical Indicator 12483M Company · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −5 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| −4 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| −3 | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| −2 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| −1 | K192937 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| 0 (this device) | K203458 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2020 | — |
| +1 | K222508 | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K192937 | 3M Comply Hydrogen Peroxide Chemical IndicatorSummary page 5…Physical/chemical sterilization process indicators Device Classification: Class II, 21 CFR 880.2800(b) Product Code: JOJ 2. Predicate Device: K192937, 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 3. Description of Device: The 3M™ Comply™ Hydrogen Peroxide Chemical In… | 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 |
|---|---|---|---|
| K222508 | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 | 2022 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K222508 (3M Company, 2022) 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. 2020, 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?
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hyrdogen peroxide in the following sterilizers and cycles. STERRAD 100® Sterilization System STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization…
Read the full statement (166 words)
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify
exposure to vaporized hyrdogen peroxide in the following sterilizers and cycles.
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
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/K203458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203458: 3M Comply Hydrogen Peroxide Chemical Indicator 1248.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203458
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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