510(k) · Cleared

Recalled · Class II · 2015

Cidex Activated Dialdehyde Solution

K060618510(k) SpecialCleared Apr 12, 200635-day reviewClass II21 CFR 880.6885Recalls 1

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

Johnson & Johnson Co. · MED Sterilant, Medical Devices

Cleared on Apr 12, 2006 as substantially equivalent to K924434 (Johnson & Johnson Medical, Inc., 1994) after a 35-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.

Decided: Apr 12, 2006
Review: 35 days
Class: Class II
Product code: MED
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K924434 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK924434 Cidex Activated Dialdehyde SolutionJohnson & Johnson Medical, Inc. · 1994
This deviceK060618 Cidex Activated Dialdehyde SolutionJohnson & Johnson Co. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924434	Cidex Activated Dialdehyde Solution	Johnson & Johnson Medical, Inc.	1994	—
0 (this device)	K060618	Cidex Activated Dialdehyde Solution	Johnson & Johnson Co.	2006	—

FIG. 1 — Lineage of K060618, 1994–2006Source: 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 MED? 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 MED device

#1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 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
*	K924434	Cidex Activated Dialdehyde Solution Summary page 1 …Name Liquid Chemical Sterilant Classification Class II Legally Marketed Equivalent Device CIDEX® Activated Dialdehyde Solution, K924434 Description of Device CIDEX Solution is a liquid chemical sterilant/high level disinfectant used for ste…	Johnson & Johnson Medical, Inc.	1994	—

Also cleared against K924434: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 27, 2015	Class II	Z-2459-2015	Device Design	Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K924434.

How does its category compare?

All MED devices

MED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MED

2in 2023

2007high 6 (2010) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MED

84in 2019

2007high 281 (2010) · low 84 (2019)2026

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

Recalls per year · MED

2in 2011

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · MED

9in 2025

2007high 337 (2012) · low 8 (2024)2025

MAUDE reports naming product code MED, 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	—	3	34
2008	1	—	2	79
2009	0	—	0	158
2010	6	281	0	89
2011	0	—	2	106
2012	3	111	0	337
2013	1	—	0	140
2014	1	—	0	105
2015	0	—	0	110
2016	1	—	0	135
2017	1	—	0	74
2018	2	—	0	42
2019	4	84	0	35
2020	0	—	0	32
2021	2	—	0	31
2022	1	—	0	16
2023	2	—	0	9
2024	0	—	0	8
2025	0	—	0	9
2026	2	—	0	—

What is it indicated for?

CIDEX® Activated Dialdehyde Solution is a liquid chemical sterilant and a high level disinfectant for reprocessing heat sensitive medical/dental devices such as endoscopes, respiratory therapy equipment and ultrasonic transducers. Sterilant: CIDEX Solution is a sterilant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25°C (770) with an…

Read the full statement (156 words)

Sterilant:

CIDEX Solution is a sterilant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25°C (770) with an immersion time of at least 10 hours with a reuse period not to exceed 14 days.

High Level Disinfectant:

CIDEX Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 250 C (770) with an immersion time of at least 45 minutes with a reuse period not to exceed 14 days.

CIDEX Solution is intended for use in manual systems as well as in automated endoscope reprocessors.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060618 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060618: Cidex Activated Dialdehyde Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060618

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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