510(k) · Cleared
Cleared3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
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 23, 2022 as substantially equivalent to K212081 (3M Company, 2021) after a 65-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Sep 23, 2022
- Review
- 65 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945190 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK945190 Sterrad Chemical Indicator TapeAdvanced Sterilization Products · 1994
- 7 generations backK020589 3M Comply 1228 Gas Plasma Indicator Tape3M Company · 2002
- 6 generations backK150694 3M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2015
- 5 generations backK170563 3M Comply Hydrogen Peroxide Indicator Tape3M Company · 2017
- 4 generations backK183209 3M Comply Hydrogen Peroxide Indicator Tape3M Company · 2019
- 3 generations backK192673 3M™ Comply™ Hydrogen Peroxide Indicator Tape 12283M Company · 2019
- 2 generations backK203285 3M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2020
- 1 generation backK212081 3M (TM) Comply (TM) Hydrogen Peroxide Indicator Tape 12283M Company · 2021
- This deviceK222152 3M™ Attest™ Hydrogen Peroxide Indicator Tape 12283M Company · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945190 | Sterrad Chemical Indicator Tape | Advanced Sterilization Products | 1994 | — |
| −7 | K020589 | 3M Comply 1228 Gas Plasma Indicator Tape | 3M Company | 2002 | — |
| −6 | K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2015 | — |
| −5 | K170563 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2017 | — |
| −4 | K183209 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2019 | — |
| −3 | K192673 | 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2019 | — |
| −2 | K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2020 | — |
| −1 | K212081 | 3M (TM) Comply (TM) Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2021 | — |
| 0 (this device) | K222152 | 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2022 | — |
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 |
|---|---|---|---|
| * | K212081 | 3M (TM) Comply (TM) Hydrogen Peroxide Indicator Tape 1228Summary page 5…al/chemical sterilization process Device Classification Class II, 21 CFR § 880.2800 Product Code JOJ 2. Predicate Device: K212081, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 3. Description of Device: The 3M™ Attest™ Hydrogen Peroxide Indicator… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
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?
Use the 3M ™ Attest ™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the following sterilizers: 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…
Read the full statement (188 words)
Use the 3M ™ Attest ™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the following sterilizers:
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)
STERIZONE® VP4 Sterilizer (Cycle 1)
The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222152: 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222152
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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