510(k) · Cleared
ClearedSystem 83 Plus Washer/Disinfector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Ultrasonics, Inc. · FEB Accessories, Cleaning, For Endoscope
Cleared on Mar 30, 2020 as substantially equivalent to K122172 (Custom Ultrasonics, 2013) after an 860-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Mar 30, 2020
- Review
- 860 days
- Class
- Class II
- Product code
- FEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122172 (2013). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122172 | System 83 Plus | Custom Ultrasonics | 2013 | 1 |
| 0 (this device) | K173590 | System 83 Plus Washer/Disinfector | Custom Ultrasonics, Inc. | 2020 | — |
| +1 | K241168 | System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K122172 | System 83 PlusSummary page 4…ass: II Product Code: FEB 3. Predicate Device Custom Ultrasonics, Inc., System 83 Plus™ Endoscope Washer/Disinfector, K122172 4. Device Description The System 83 Plus™ is an automated, computer controlled, electro-mechanical system intended… | 2013 |
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 |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/Disinfector | 2024 | 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?
- Its one ancestor has a recall.
- Of its descendants, K241168 (Wassenburg Medical, Inc., 2024) has gone furthest, with 0 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. 2020, 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?
System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are pre-cleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plus™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact…
Read the full statement (138 words)
System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are pre-cleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plus™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant.
Note: The System 83 Plus™ device includes two models.
* The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time.
* The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173590 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173590: System 83 Plus Washer/Disinfector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173590
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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