510(k) · Cleared
Recalled · Class II · 2013System 83 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Ultrasonics · FEB Accessories, Cleaning, For Endoscope
Cleared on Jan 25, 2013 after a 186-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 25, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- FEB
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK122172 System 83 PlusCustom Ultrasonics · 2013
- Descendant · cites it directly · 1 of its ownK173590 System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK241168 System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc. · 2024
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 |
|---|---|---|---|---|---|
| 0 (this device) | K122172 | System 83 Plus | Custom Ultrasonics | 2013 | — |
| +1 | K173590 | System 83 Plus Washer/Disinfector | Custom Ultrasonics, Inc. | 2020 | — |
| +2 | K241168 | System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173590 | System 83 Plus Washer/Disinfector | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2013 | Class II | Z-0426-2014 | Software design | Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K173590 (Custom Ultrasonics, Inc., 2020) has gone furthest, with 1 descendant 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. 2013, 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 Endoscope Washerlbisinfector is designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinai and/or pulmonary tracts. Flexible scopes that are precleaned and then exposed to the.washngdisnfeclOfl cycle of the System 83 Plus may be high level disintected when the disinfection cycle corresponds to the labeled contact conditions for the germicide as In the predicated device.…
Read the full statement (130 words)
System 83 Plus Endoscope Washerlbisinfector is designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinai and/or pulmonary tracts. Flexible scopes that are precleaned and then exposed to the.washngdisnfeclOfl cycle of the System 83 Plus may be high level disintected when the disinfection cycle corresponds to the labeled contact conditions for the germicide as In the predicated device.
Note: System 83 Plus device Includes two models.
The System 83 Plus 2 Isa device with one processing chamber which can process I to 2 flexible endo scopes at a time.
The System 83 Plus 9 Is two 'System 83 Plus 2' units put together. It has two processing chambers which can process 1 to 2 flexible endoscopes in each Independently operated processing chamber.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122172: System 83 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122172
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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