510(k) · Cleared

Cleared

Cidex Opa Concentrate

K032959510(k) TraditionalCleared Apr 4, 2005559-day reviewClass II21 CFR 880.6885

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

Advanced Sterilization Products · MED Sterilant, Medical Devices

Cleared on Apr 4, 2005 as substantially equivalent to K991487 (Advanced Sterilization Products, 1999) and 1 other predicate after a 559-day review. Its family tree reaches back 1 generation to 1988.

Decided: Apr 4, 2005
Review: 559 days
Class: Class II
Product code: MED
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K875280 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK875280 Steris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc. · 1988 · Recalled
This deviceK032959 Cidex Opa ConcentrateAdvanced Sterilization Products · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K875280	Steris System 1 Processor and 20 Sterilant	Steris C/O Medical Device Consultants, Inc.	1988	3
0 (this device)	K032959	Cidex Opa Concentrate	Advanced Sterilization Products	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K032959, 1988–2005Source: 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? (2)

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
*	K991487	Cidex Opa Solution Summary page 1 …CIDEX*' OPA Concentrate In-Use solution claims equivalence to the device following legally marketed medical devices: CIDEX®" OPA Solution (K99 1487) and Steris 2OTM Sterilant/ Steris System ITM (K875280) Device CIDEX' OPA Concentrate is formulated to contain 5.75…	Advanced Sterilization Products	1999	—
*	K875280	Steris System 1 Processor and 20 Sterilant Summary page 1 …ce to the device following legally marketed medical devices: CIDEX®" OPA Solution (K99 1487) and Steris 2OTM Sterilant/ Steris System ITM (K875280) Device CIDEX' OPA Concentrate is formulated to contain 5.75% w/v of description ortho-phthalaldehyde. The r…	Steris C/O Medical Device Consultants, Inc.	1988	3

Also cleared against K991487: 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K991487.

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® OPA Concentrate is a high level disinfectant (HLD) at the minimum IN USE concentration of 0.055% with a contact time of 5 minutes at 50°C for reprocessing heat sensitive (<60°C) semi-critical endoscopes when used according to the Directions for Use.

CIDEX® OPA Concentrate is intended for use in the ASP EvoTech™ System. THIS PRODUCT IS NOT INTENDED FOR MANUAL USE. See Directions for Use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032959 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032959: Cidex Opa Concentrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032959

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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