510(k) · Cleared
Recalled · Class II · 2023Advantage Plus Pass-Thru
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivators, Inc. · FEB Accessories, Cleaning, For Endoscope
Cleared on Dec 19, 2017 as substantially equivalent to K082988 (Medivators Reprocessing Systems, 2009) and 1 other predicate after a 105-day review. Its family tree reaches back 4 generations to 1994. It has been recalled once.
- Decided
- Dec 19, 2017
- Review
- 105 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914145 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK172677 Advantage Plus Pass-ThruMedivators, Inc. · 2017
View 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) | K172677 | Advantage Plus Pass-Thru | Medivators, Inc. | 2017 | — |
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 |
| 2011 | 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 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? (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 |
|---|---|---|---|
| * | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Summary page 4…Predicate Device Trade Name – Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant (K082988 and K102996), 876.1500 1. Indications for Use Advantage Plus Pass-Thru Endoscope Reprocessing System… | 2009 |
| * | K102996 | Medivators Advantage Plus Endoscope ReprocessorSummary page 4…Trade Name – Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant (K082988 and K102996), 876.1500 1. Indications for Use Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfects and rinses… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 23 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K082988.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System. The Advantage Plus Pass-Thru…
Read the full statement (159 words)
Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.
The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.
Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm 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 –
Contact Time: 5 minutes
Temperature: 30°C
MRC: 850ppm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172677: Advantage Plus Pass-Thru.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172677
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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