510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Modification to System 83 Plus

K983017510(k) SpecialCleared Sep 22, 199825-day reviewClass II21 CFR 876.1500Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Custom Ultrasonics · NVE Washer, Cleaner, Automated, Endoscope

Cleared on Sep 22, 1998 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it. It has been recalled 2 times.

Decided
Sep 22, 1998
Review
25 days
Class
Class II
Product code
NVE
Recalls
2
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2019: 1 descendant cleared2020: 2 descendants cleared2022: 2 descendants cleared1995200020052010201520202025
  1. This deviceK983017 Modification to System 83 PlusCustom Ultrasonics · 1998
  2. Descendant · cites it directly · 8 of its ownK043314 Manzi Cleaner SystemLangford IC Systems, Inc. · 2005
  3. Descendant · 2 generations on · 5 of its ownK073112 DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc. · 2008
  4. Descendant · 3 generations on · 4 of its ownK190081 RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP…STERIS Corporation · 2019
  5. Descendant · 4 generations on · 3 of its ownK200577 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP…STERIS Corporation · 2020
  6. Descendant · 5 generations on · 2 of its ownK203199 RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP /…STERIS Corporation · 2020

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 12011: 12019: 12020: 22022: 2
2005high 2 (2020) · low 0 (2007)2026

Most influential descendants

Showing 5 of 9 · See all
  • K043314Manzi Cleaner SystemLangford IC Systems, Inc. · 2005 · cites it directly8descendants
  • K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc. · 2008 · 2 generations on5descendants
  • K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation · 2019 · 3 generations on4descendants
  • K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation · 2020 · 4 generations on3descendants
  • K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation · 2020 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983017Modification to System 83 PlusCustom Ultrasonics1998—
+1K043314Manzi Cleaner SystemLangford IC Systems, Inc.2005—
+2K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.2008—
+3K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation2019—
+4K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single…STERIS Corporation2020—
+5K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP…STERIS Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200810
201110
201910
202020
202220
FIG. 1 — Lineage of K983017, 1998–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NVE? 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 NVE device

  1. #1 K222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low…score 10.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043314Manzi Cleaner SystemLangford IC Systems, Inc.20058
K060458Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant…Langford IC Systems, Inc.20061

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 12, 2013Class IIZ-0426-2014Software designCertain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
Feb 11, 2008Not classifiedZ-1182-2008Labeling designInadvertent selection of the "wash" cycle

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K043314 (Langford IC Systems, Inc., 2005) has gone furthest, with 8 descendants of its own.

How does its category compare?

All NVE devices

NVE Washer, Cleaner, Automated, Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NVE

2in 2022

2008: 12019: 12020: 22022: 2
2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVE

Too few NVE 510(k)s in any year since 2007 to give a median.

Recalls per year · NVE

No recall names NVE since 2007.

Adverse event reports per year · NVE

1in 2025

2008: 202009: 2192010: 62012: 32015: 32016: 12017: 22018: 22019: 42020: 22025: 1
2007high 219 (2009) · low 0 (2007)2025

MAUDE reports naming product code NVE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—020
20090—0219
20100—06
20110—00
20120—03
20130—00
20140—00
20150—03
20160—01
20170—02
20180—02
20191—04
20202—02
20210—00
20222—00
20230—00
20240—00
20250—01
20260—0—

What is it indicated for?

I certify that, in my capacity as President of Custom Ultrasonics, Inc., that the System 83 Plus Endoscope Washer/Disinfector is designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible scopes that are precleaned 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 labeled contact conditions for the germicide as in the predicated device

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Custom Ultrasonics

4 FDA decisions under this applicant name. See the company

  • K122172System 83 PlusCustom Ultrasonics · 20131 recall
  • K061430System 83 Plus Miniflex Washer-DisinfectorCustom Ultrasonics · 20071 recall
  • K842754Custom Ultrasonics-Sys 80, 81-24, 83-2Custom Ultrasonics · 1984

Recent decisions in NVE

The NVE category page

  • K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature…Steris · 2022
  • K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature…Steris · 2022
  • K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-DisinfectorSTERIS Corporation · 2020
  • K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS Corporation · 2020
  • K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS Corporation · 2019

https://510kreport.com/device/K983017 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983017: Modification to 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/K983017

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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