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 Apr 1, 2011 as substantially equivalent to K022441 (Advanced Sterilization Products, 2002) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 2002. 4 later devices descend from it.
- Decided
- Apr 1, 2011
- Review
- 151 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022441 (2002). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK022441 Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2002
- 1 generation backK040742 Modification to Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2004
- This deviceK103219 Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2011
- Descendant · cites it directly · 3 of its ownK111519 Sterrad Sealsure Chemical Indicator Tape Model 14202Advanced Sterilization Products · 2012
- Descendant · 2 generations on · 1 of its ownK160485 VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE®…Advanced Sterilization Products, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK172753 VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2018
Most influential descendants
Showing 4 of 4 · See all- K111519Sterrad Sealsure Chemical Indicator Tape Model 14202Advanced Sterilization Products · 2012 · cites it directly3descendants
- K160485VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2016 · 2 generations on1descendant
- K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…Advanced Sterilization Products, Inc. · 2024 · 2 generations on0descendants
- K172753VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022441 | Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2002 | — |
| −1 | K040742 | Modification to Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2004 | — |
| 0 (this device) | K103219 | Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2011 | — |
| +1 | K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202 | Advanced Sterilization Products | 2012 | — |
| +2 | K160485 | VERIFY VH2O2 Indicator Tape | STERIS Corporation | 2016 | — |
| +2 | K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical… | Advanced Sterilization Products, Inc. | 2024 | — |
| +3 | K172753 | VERIFY VH2O2 Indicator Tape | STERIS Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K022441 | Sterrad Sealsure Chemical Indicator TapeSummary page 1…l Sterilization Process Indicator Product Classification: 11 Proprietary Name: STERRAD® SEALSURE® Chemical Indicator Tape 2. PREDICATE DEVICES * K022441, cleared on October 8, 2002 * K040742, cleared on April 2, 2004 2 === Page 2… | 2002 |
| * | K040742 | Modification to Sterrad Sealsure Chemical Indicator TapeSummary page 1…t Classification: 11 Proprietary Name: STERRAD® SEALSURE® Chemical Indicator Tape 2. PREDICATE DEVICES * K022441, cleared on October 8, 2002 * K040742, cleared on April 2, 2004 2 3. INDICATIONS FOR USE STERRAD® SEA… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202 | 2012 | 3 |
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 9 years and passes through 1 company; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111519 (Advanced Sterilization Products, 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K022441.
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. 2011, 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?
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator [(Class 1 Process Indicator (ISO 11140-1)] intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems.
MODEL — CYCLE
STERRAD® 1005S — Standard
STERRAD® 50 — Standard
STERRAD® 200 — Standard
STRASNX — Standard
STERRAD® Advanced — Standard
STERRAD® 100ONX — Flex
EXPRESS
The color of the STERRAD®D 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103219: Sterrad Sealsure Chemical 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/K103219
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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