510(k) · Cleared
ClearedVERIFY VH2O2 Indicator Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jun 1, 2016 as substantially equivalent to K111519 (Advanced Sterilization Products, 2012) after a 100-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Jun 1, 2016
- Review
- 100 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022441 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK022441 Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2002
- 3 generations backK040742 Modification to Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2004
- 2 generations backK103219 Sterrad Sealsure Chemical Indicator TapeAdvanced Sterilization Products · 2011
- 1 generation backK111519 Sterrad Sealsure Chemical Indicator Tape Model 14202Advanced Sterilization Products · 2012
- This deviceK160485 VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2016
- Descendant · cites it directly · 0 of its ownK172753 VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K172753VERIFY VH2O2 Indicator TapeSTERIS Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022441 | Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2002 | — |
| −3 | K040742 | Modification to Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2004 | — |
| −2 | K103219 | Sterrad Sealsure Chemical Indicator Tape | Advanced Sterilization Products | 2011 | — |
| −1 | K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202 | Advanced Sterilization Products | 2012 | — |
| 0 (this device) | K160485 | VERIFY VH2O2 Indicator Tape | STERIS Corporation | 2016 | — |
| +1 | K172753 | VERIFY VH2O2 Indicator Tape | STERIS Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202Summary page 5…Sterilization Process Indicator (21 CFR 880.2800, JOJ) 2. Predicate Device STERRAD® SealsureTM Chemical Indicator Tape (K111519) 3. Description of Device The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal l… | 2012 |
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 |
|---|---|---|---|
| K172753 | VERIFY VH2O2 Indicator Tape | 2018 | 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 14 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K172753 (STERIS Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111519.
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. 2016, 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?
The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter.
The tape may be used in the following sterilization cycles:
• Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
• Standard Cycle of the STERRAD® 100S Sterilizer
• Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160485: VERIFY VH2O2 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/K160485
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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