510(k) · Cleared
Recalled · Class II · 2026Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivators Reprocessing Systems · FEB Accessories, Cleaning, For Endoscope
Cleared on Feb 13, 2009 as substantially equivalent to K063876 (Medivators Reprocessing Systems, 2007) and 3 other predicates after a 129-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 13, 2009
- Review
- 129 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 3 generations to K914145 (1994). 7 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
- 2 generations backK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · Recalled
- 1 generation backK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · Recalled
- This deviceK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009
- Descendant · cites it directly · 2 of its ownK152394 Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK251035 DISINTEK™ PA Test StripsSerim Research · 2025
- Descendant · 2 generations on · 0 of its ownK251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK233049 TD 200® Automated TEE Probe Disinfector with TD-12® High-Level…Cs Medical, LLC · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016 · cites it directly2descendants
- K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC · 2020 · cites it directly1descendant
- K251035DISINTEK™ PA Test StripsSerim Research · 2025 · 2 generations on0descendants
- K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025 · 2 generations on0descendants
- K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with…Cs Medical, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | 1 |
| −2 | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | 3 |
| −1 | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | 2 |
| 0 (this device) | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High… | Medivators Reprocessing Systems | 2009 | — |
| +1 | K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016 | — |
| +1 | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical… | Cs Medical, LLC | 2020 | — |
| +2 | K251035 | DISINTEK™ PA Test Strips | Serim Research | 2025 | — |
| +2 | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | 2025 | — |
| +2 | K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant… | Cs Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 FEB? 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 FEB device
- #1 K243433 enspire 3000 Cleaning and Liquid Chemical…score 10.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K063876 | Modular Disinfection System (MDS) for Endoscope ReprocessingSummary page 3…on Within the United States The Advantage Plus is equivalent in function and indications to the Medivators MDS Endoscope Reprocessing System (K063876) and the Advanced Sterilization Products' EvoTech TM Integrated Endoscope Disinfection System (K061899). All of… | 2007 |
| * | K061899 | Evotech Integrated Endoscope Disinfection SystemSummary page 3…Medivators MDS Endoscope Reprocessing System (K063876) and the Advanced Sterilization Products' EvoTech TM Integrated Endoscope Disinfection System (K061899). All of the machines have the same indications for use and the same methods of providing disinfection. Rapici… | 2006 |
| * | K041984 | Acecide High-Level Disinfectant and SterilantSummary page 3…f providing disinfection. Rapicide PA High Level Disinfectant is equivalent in indications and usage to Acecide High Level Disinfectant and Sterilant (K041984) and Peract 20 Liquid Sterilant (K960513). All of the products are peracetic acid based germicides labeled for… | 2005 |
| * | K960513 | Peract 20 Liquid SterilantSummary page 3…gh Level Disinfectant is equivalent in indications and usage to Acecide High Level Disinfectant and Sterilant (K041984) and Peract 20 Liquid Sterilant (K960513). All of the products are peracetic acid based germicides labeled for providing high level disinfection to flex… | 1997 |
What descends from it? (7)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2026 | Class II | Z-0156-2027 | Process change control | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which… |
| Sep 21, 2026 | Class II | Z-0154-2027 | Process change control | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which… |
| Sep 21, 2026 | Class II | Z-0155-2027 | Process change control | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which… |
| Nov 13, 2023 | Class II | Z-0617-2024 | Process control | Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K152394 (Medivators, Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FEB
111in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEB
15so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEB
356in 2025
MAUDE reports naming product code FEB, 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 | 2 | — | 0 | 39 |
| 2008 | 1 | — | 3 | 152 |
| 2009 | 1 | — | 0 | 20 |
| 2010 | 2 | — | 1 | 50 |
| 2011 | 3 | 111 | 0 | 32 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 27 |
| 2014 | 1 | — | 0 | 48 |
| 2015 | 0 | — | 0 | 92 |
| 2016 | 2 | — | 2 | 103 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 2 | — | 0 | 62 |
| 2020 | 2 | — | 1 | 426 |
| 2021 | 0 | — | 1 | 575 |
| 2022 | 1 | — | 0 | 607 |
| 2023 | 1 | — | 1 | 998 |
| 2024 | 2 | — | 1 | 884 |
| 2025 | 0 | — | 3 | 356 |
| 2026 | 1 | — | 15 | — |
What is it indicated for?
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system. Rapicide PA High Level Disinfectant is intended for use with the…
Read the full statement (141 words)
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system.
Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions:
High Level Disinfection — 5 minutes — 30(°C) — 850ppm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082988
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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