510(k) · Cleared
Recalled · 2010DSD-91(TM) Disinfector for Flexible Endoscopes
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 Feb 22, 1994 after an 890-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 34 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 1994
- Review
- 890 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 1
- Predicates
- 0
34 later devices descend from it, 5 citing it directly.
- This deviceK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994
- Descendant · cites it directly · 18 of its ownK040883 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · Recalled
- Descendant · 2 generations on · 17 of its ownK061899 Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · Recalled
- Descendant · cites it directly · 9 of its ownK051305 CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100…Cs Medical, LLC · 2005
- Descendant · cites it directly · 8 of its ownK063876 Modular Disinfection System (MDS) for Endoscope ReprocessingMedivators Reprocessing Systems · 2007
- Descendant · 2 generations on · 7 of its ownK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K040883Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2005 · cites it directly18descendants
- K061899Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products · 2006 · 2 generations on17descendants
- K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5…Cs Medical, LLC · 2005 · cites it directly9descendants
- K063876Modular Disinfection System (MDS) for Endoscope ReprocessingMedivators Reprocessing Systems · 2007 · cites it directly8descendants
- K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems · 2009 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914145 | DSD-91(TM) Disinfector for Flexible Endoscopes | Medivators, Inc. | 1994 | — |
| +1 | K040883 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2005 | 3 |
| +2 | K061899 | Evotech Integrated Endoscope Disinfection System | Advanced Sterilization Products | 2006 | 2 |
| +1 | K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical… | Cs Medical, LLC | 2005 | — |
| +1 | K063876 | Modular Disinfection System (MDS) for Endoscope Reprocessing | Medivators Reprocessing Systems | 2007 | — |
| +2 | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High… | Medivators Reprocessing Systems | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (34)
See all 345 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040883 | Evotech Integrated Endoscope Disinfection System | 2005 | 18 |
| K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5… | 2005 | 9 |
| K063876 | Modular Disinfection System (MDS) for Endoscope Reprocessing | 2007 | 8 |
| K093106 | Endoscope Reprocessor Oer-Pro | 2010 | 5 |
| K092387 | Medivators DSD Edge Endoscope Reprocessing System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2010 | Not classified | Z-2213-2010 | Labeling False and Misleading | The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040883 (Advanced Sterilization Products, 2005) has gone furthest, with 18 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.
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 | — |
https://510kreport.com/device/K914145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914145: DSD-91(TM) Disinfector for Flexible Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914145
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026