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 Aug 14, 2017 as substantially equivalent to K150622 (3M Company, 2015) after a 194-day review. Its family tree reaches back 3 generations to 1993. 12 later devices descend from it.
- Decided
- Aug 14, 2017
- Review
- 194 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921910 (1993). 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 2 generations backK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- 1 generation backK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- This deviceK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- Descendant · cites it directly · 11 of its ownK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- Descendant · 2 generations on · 7 of its ownK193110 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Healthcare · 2020 · Recalled
- Descendant · 3 generations on · 6 of its ownK203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020
- Descendant · 4 generations on · 3 of its ownK213262 CELERITY HP Chemical IndicatorSTERIS Corporation · 2022
- Descendant · 5 generations on · 2 of its ownK231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K1832113M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019 · cites it directly11descendants
- K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Healthcare · 2020 · 2 generations on7descendants
- K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020 · 3 generations on6descendants
- K213262CELERITY HP Chemical IndicatorSTERIS Corporation · 2022 · 4 generations on3descendants
- K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −2 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| −1 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| 0 (this device) | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| +1 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| +2 | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020 | 1 |
| +3 | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020 | — |
| +4 | K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022 | — |
| +5 | K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical… | Steris | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248Summary page 4…800) Device Classification: Class II Product Code: JOJ Predicate Device: 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K150622) Description of Device: The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a non- cellulosic plastic materi… | 2015 |
| † | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | 2002 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 2019 | 11 |
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 24 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K183211 (3M Company, 2019) has gone furthest, with 11 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. 2017, 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 hydrogen peroxide in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles), 100NX® (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. The chemical indicator bar turns from blue to pink after exposure to vaporized hydrogen peroxide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170321: 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/K170321
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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