510(k) · Cleared
Cleared3M (TM) Comply (TM) 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 5, 2021 as substantially equivalent to K203285 (3M Company, 2020) after a 65-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Sep 5, 2021
- Review
- 65 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945190 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK945190 Sterrad Chemical Indicator TapeAdvanced Sterilization Products · 1994
- 6 generations backK020589 3M Comply 1228 Gas Plasma Indicator Tape3M Company · 2002
- 5 generations backK150694 3M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2015
- 4 generations backK170563 3M Comply Hydrogen Peroxide Indicator Tape3M Company · 2017
- 3 generations backK183209 3M Comply Hydrogen Peroxide Indicator Tape3M Company · 2019
- 2 generations backK192673 3M™ Comply™ Hydrogen Peroxide Indicator Tape 12283M Company · 2019
- 1 generation backK203285 3M Comply Hydrogen Peroxide Indicator Tape 12283M Company · 2020
- This deviceK212081 3M (TM) Comply (TM) Hydrogen Peroxide Indicator Tape 12283M Company · 2021
- Descendant · cites it directly · 0 of its ownK222152 3M™ Attest™ Hydrogen Peroxide Indicator Tape 12283M Company · 2022
Most influential descendants
Showing 1 of 1 · See all- K2221523M™ Attest™ Hydrogen Peroxide Indicator Tape 12283M Company · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945190 | Sterrad Chemical Indicator Tape | Advanced Sterilization Products | 1994 | — |
| −6 | K020589 | 3M Comply 1228 Gas Plasma Indicator Tape | 3M Company | 2002 | — |
| −5 | K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2015 | — |
| −4 | K170563 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2017 | — |
| −3 | K183209 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2019 | — |
| −2 | K192673 | 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2019 | — |
| −1 | K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2020 | — |
| 0 (this device) | K212081 | 3M (TM) Comply (TM) Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2021 | — |
| +1 | K222152 | 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 | 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 |
|---|---|---|---|
| * | K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228Summary page 5…/chemical sterilization process Device Classification: Class II, 21 CFR § 880.2800 Product Code: JOJ 2. Predicate Device: K203285 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 3. Description of Device: The 3M™ Comply™ Hydrogen Peroxide Indicato… | 2020 |
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 |
|---|---|---|---|
| K222152 | 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 | 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 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K222152 (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. 2021, 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 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 (186 words)
Use the 3M™ Comply™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212081: 3M (TM) Comply (TM) 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/K212081
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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