510(k) · Cleared
Cleared3M Comply 1228 Gas Plasma Indicator Tape
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 Apr 22, 2002 as substantially equivalent to K945190 (Advanced Sterilization Products, 1994) after a 59-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.
- Decided
- Apr 22, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945190 (1994). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945190 Sterrad Chemical Indicator TapeAdvanced Sterilization Products · 1994
- This deviceK020589 3M Comply 1228 Gas Plasma Indicator Tape3M Company · 2002
- Descendant · cites it directly · 6 of its ownK150694 3M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2015
- Descendant · 2 generations on · 5 of its ownK170563 3M Comply Hydrogen Peroxide Indicator Tape3M Company · 2017
- Descendant · 3 generations on · 4 of its ownK183209 3M Comply Hydrogen Peroxide Indicator Tape3M Company · 2019
- Descendant · 4 generations on · 3 of its ownK192673 3M™ Comply™ Hydrogen Peroxide Indicator Tape 12283M Company · 2019
- Descendant · 5 generations on · 2 of its ownK203285 3M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K1506943M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2015 · cites it directly6descendants
- K1705633M Comply Hydrogen Peroxide Indicator Tape3M Company · 2017 · 2 generations on5descendants
- K1832093M Comply Hydrogen Peroxide Indicator Tape3M Company · 2019 · 3 generations on4descendants
- K1926733M™ Comply™ Hydrogen Peroxide Indicator Tape 12283M Company · 2019 · 4 generations on3descendants
- K2032853M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945190 | Sterrad Chemical Indicator Tape | Advanced Sterilization Products | 1994 | — |
| 0 (this device) | K020589 | 3M Comply 1228 Gas Plasma Indicator Tape | 3M Company | 2002 | — |
| +1 | K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2015 | — |
| +2 | K170563 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2017 | — |
| +3 | K183209 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2019 | — |
| +4 | K192673 | 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2019 | — |
| +5 | K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K945190 | Sterrad Chemical Indicator TapeSummary page 2…he 3M Comply™ 1228 Gas Plasma.-Indicator Tape is Equivalence: comparable in performance to the Advanted Sterilization Products (ASP) STERRAD® Gas Plasma Indicator Tape (K945190). The 3M Comply 1228 Gas Plasma Indicator Tape and the predicate device share the same intended use to secure packs and as extern… | 1994 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 2015 | 6 |
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, K150694 (3M Company, 2015) has gone furthest, with 6 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.
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™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack indicator to differentiate processed from unprocessed items when exposure to vapor hydrogen peroxide in the STERRAD® sterilization processes (100, 100S, 50). The 3M Comply 1228 is suitable for use on non-woven disposable wraps and peel pouches. The diagonal stripes of chemical indicator ink turn from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes.
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/K020589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020589: 3M Comply 1228 Gas Plasma Indicator Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020589
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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