510(k) · Cleared
ClearedRapicide PA High-Level Disinfectant Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivators, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Mar 11, 2016 as substantially equivalent to K082988 (Medivators Reprocessing Systems, 2009) and 2 other predicates after a 200-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 11, 2016
- Review
- 200 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K914145 (1994). 10 ancestors in all, the oldest K931935 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 3 generations backK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · Recalled
- 2 generations backK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · Recalled
- 1 generation backK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009 · Recalled
- This deviceK152394 Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK251035 DISINTEK™ PA Test StripsSerim Research · 2025
- Descendant · cites it directly · 0 of its ownK251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −3 | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | 3 |
| −2 | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | 2 |
| −1 | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High… | Medivators Reprocessing Systems | 2009 | 4 |
| 0 (this device) | K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016 | — |
| +1 | K251035 | DISINTEK™ PA Test Strips | Serim Research | 2025 | — |
| +1 | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Summary page 5…ame: Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ) 2. Predicate Device Information: K082988/K964264 - Rapicide PA Test Strips K931935 –Endpoint 500 Peracetic Acid Test Indicators 3.Intended Use: The Rapicide PA Hi… | 2009 |
| * | K964264 | High Range Peroxide Test StripSummary page 5…Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ) 2. Predicate Device Information: K082988/K964264 - Rapicide PA Test Strips K931935 –Endpoint 500 Peracetic Acid Test Indicators 3.Intended Use: The Rapicide PA High-Level… | 1997 |
| * | K931935 | Endpoint 500 Peracetic Acid Test IndicatorsSummary page 5…ocess indicator (21 CFR 880.2800 (b), Product Code JOJ) 2. Predicate Device Information: K082988/K964264 - Rapicide PA Test Strips K931935 –Endpoint 500 Peracetic Acid Test Indicators 3.Intended Use: The Rapicide PA High-Level Disinfectant Test Strips are used as… | 1994 |
What descends from it? (2)
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K251035 (Serim Research, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K082988.
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 Rapicide PA High-Level Disinfectant Test Strips are used as a chemical indicator after the disinfection cycle to ensure that the Rapicide PA High-Level Disinfectant Solution is above minimum recommended concentration (850ppm peracetic acid); this ensures the disinfectant was above MRC during the entire disinfection cycle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152394: Rapicide PA High-Level Disinfectant Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152394
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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