510(k) · Cleared

Cleared

Modular Disinfection System (MDS) for Endoscope Reprocessing

K063876510(k) TraditionalCleared Jun 14, 2007167-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

Medivators Reprocessing Systems · FEB Accessories, Cleaning, For Endoscope

Cleared on Jun 14, 2007 as substantially equivalent to K914145 (Medivators, Inc., 1994) after a 167-day review. Its family tree reaches back 1 generation to 1994. 8 later devices descend from it.

Decided: Jun 14, 2007
Review: 167 days
Class: Class II
Product code: FEB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K914145 (1994). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
This deviceK063876 Modular Disinfection System (MDS) for Endoscope ReprocessingMedivators Reprocessing Systems · 2007
Descendant · cites it directly · 7 of its ownK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009 · Recalled
Descendant · 2 generations on · 2 of its ownK152394 Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016
Descendant · 2 generations on · 1 of its ownK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
Descendant · 3 generations on · 0 of its ownK251035 DISINTEK™ PA Test StripsSerim Research · 2025
Descendant · 3 generations on · 0 of its ownK251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009high 2 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 8 · See all

K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems · 2009 · cites it directly7descendants
K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016 · 2 generations on2descendants
K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC · 2020 · 2 generations on1descendant
K251035DISINTEK™ PA Test StripsSerim Research · 2025 · 3 generations on0descendants
K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914145	DSD-91(TM) Disinfector for Flexible Endoscopes	Medivators, Inc.	1994	1
0 (this device)	K063876	Modular Disinfection System (MDS) for Endoscope Reprocessing	Medivators Reprocessing Systems	2007	—
+1	K082988	Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High…	Medivators Reprocessing Systems	2009	4
+2	K152394	Rapicide PA High-Level Disinfectant Test Strips	Medivators, Inc.	2016	—
+2	K192228	CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical…	Cs Medical, LLC	2020	—
+3	K251035	DISINTEK™ PA Test Strips	Serim Research	2025	—
+3	K251048	Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118	STERIS Corporation	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2016	1	0
2017	1	0
2020	1	0
2023	1	0
2025	2	0

FIG. 1 — Lineage of K063876, 1994–2025Source: 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 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 10.9 · 9 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
*	K914145	DSD-91(TM) Disinfector for Flexible Endoscopes Summary page 2 …MDS is equivalent in function and indications to the Medivators DSD-9IETm Endoscope Disinfector. This machine was found to be substantially equivalent in 1994 (K914145). Both machines have the same indications for use, the same methods of providing disinfection, can use the same reuseab…	Medivators, Inc.	1994	1

Also cleared against K914145: 4 other devices →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082988	Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…	Medivators Reprocessing Systems	2009	7

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, K082988 (Medivators Reprocessing Systems, 2009) has gone furthest, with 7 descendants of its own.
4 other devices also cite its predicate K914145.

How does its category compare?

All FEB devices

FEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FEB

2in 2024

2007high 3 (2011) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEB

111in 2011

2007high 111 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FEB

15so far in 2026, the most since 2007

2007high 15 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FEB

356in 2025

2007high 998 (2023) · low 16 (2012)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?

Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing tests, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The MDS is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes, It is indicated for use with FDA cleared, liquid high level disinfectants,

The MDS does not replace manual cleaning of endosoopes, they must be preclesned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MADS.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063876 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063876: Modular Disinfection System (MDS) for Endoscope Reprocessing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063876

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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