510(k) · Cleared
ClearedSterrad Sealsure Chemical Indicator Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Oct 8, 2002 after a 75-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Oct 8, 2002
- Review
- 75 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK022441 Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2002
- Descendant · cites it directly · 5 of its ownK040742 Modification to Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2004
- Descendant · cites it directly · 4 of its ownK103219 Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2011
- Descendant · 2 generations on · 3 of its ownK111519 Sterrad Sealsure Chemical Indicator Tape Model 14202Advanced Sterilization Products · 2012
- Descendant · 3 generations on · 1 of its ownK160485 VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE®…Advanced Sterilization Products, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040742Modification to Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2004 · cites it directly5descendants
- K103219Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2011 · cites it directly4descendants
- K111519Sterrad Sealsure Chemical Indicator Tape Model 14202Advanced Sterilization Products · 2012 · 2 generations on3descendants
- K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2016 · 3 generations on1descendant
- K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…Advanced Sterilization Products, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022441 | Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2002 | — |
| +1 | K040742 | Modification to Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2004 | — |
| +1 | K103219 | Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2011 | — |
| +2 | K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202 | Advanced Sterilization Products | 2012 | — |
| +3 | K160485 | VERIFY VH2O2 Indicator Tape | STERIS Corporation | 2016 | — |
| +3 | K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical… | Advanced Sterilization Products, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | STERRAD® Chemical Indicator Tape Named without a submission number |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040742 (Advanced Sterilization Products, 2004) has gone furthest, with 5 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?
STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System.
The color of the STERRAD® SealSure™ Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads. Reference the color comparator bars on the package box label.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022441 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022441: Sterrad Sealsure Chemical Indicator Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022441
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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