510(k) · Cleared

Cleared

Manzi Cleaner System

K043314510(k) TraditionalCleared Jun 20, 2005201-day reviewClass II21 CFR 876.1500

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

Langford IC Systems, Inc. · NVE Washer, Cleaner, Automated, Endoscope

Cleared on Jun 20, 2005 as substantially equivalent to K983017 (Custom Ultrasonics, 1998) after a 201-day review. Its family tree reaches back 1 generation to 1998. 8 later devices descend from it.

Decided: Jun 20, 2005
Review: 201 days
Class: Class II
Product code: NVE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983017 (1998). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK983017 Modification to System 83 PlusCustom Ultrasonics · 1998 · Recalled
This deviceK043314 Manzi Cleaner SystemLangford IC Systems, Inc. · 2005
Descendant · cites it directly · 5 of its ownK073112 DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc. · 2008
Descendant · 2 generations on · 4 of its ownK190081 RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP…STERIS Corporation · 2019
Descendant · 3 generations on · 3 of its ownK200577 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP…STERIS Corporation · 2020
Descendant · 4 generations on · 2 of its ownK203199 RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP /…STERIS Corporation · 2020
Descendant · 5 generations on · 1 of its ownK222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006high 2 (2020) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all

K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc. · 2008 · cites it directly5descendants
K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation · 2019 · 2 generations on4descendants
K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation · 2020 · 3 generations on3descendants
K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation · 2020 · 4 generations on2descendants
K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983017	Modification to System 83 Plus	Custom Ultrasonics	1998	2
0 (this device)	K043314	Manzi Cleaner System	Langford IC Systems, Inc.	2005	—
+1	K073112	DA Vinci Sonicpro Cleaning System, Model 400253	Intuitive Surgical, Inc.	2008	—
+2	K190081	RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…	STERIS Corporation	2019	—
+3	K200577	RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single…	STERIS Corporation	2020	—
+4	K203199	RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP…	STERIS Corporation	2020	—
+5	K222543	AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System…	Steris	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2011	1	0
2019	1	0
2020	2	0
2022	2	0

FIG. 1 — Lineage of K043314, 1998–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low…score 10.8 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K983017	Modification to System 83 Plus Summary page 3 …on: 21 CFR § 876.1500, Endoscope and accessories Proprietary Name: Manzi Cleaner System 2.0 PREDICATE DEVICE System 83 PIUSTM Washer-Disinfector, K98301 7 3.0 INDICATIONS FOR USE The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent…	Custom Ultrasonics	1998	2

Also cleared against K983017: 1 other device →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K073112	DA Vinci Sonicpro Cleaning System, Model 400253	Intuitive Surgical, Inc.	2008	5
K060458	Manzi Mach 1 Instrument Cleaner-Processor System, Manzi Detergent MD10, Manzi Sterilant…	Langford IC Systems, Inc.	2006	1

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, K073112 (Intuitive Surgical, Inc., 2008) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K983017.

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

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	20
2009	0	—	219
2010	0	—	6
2011	0	—	0
2012	0	—	3
2013	0	—	0
2014	0	—	0
2015	0	—	3
2016	0	—	1
2017	0	—	2
2018	0	—	2
2019	1	—	4
2020	2	—	2
2021	0	—	0
2022	2	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	1
2026	0	—	—

What is it indicated for?

The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10, is for the cleaning of bronchoscopes in a health care setting by health care workers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043314 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043314: Manzi Cleaner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043314

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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