510(k) · Cleared

Cleared

Sporox II Sterilizing & Disinfecting Solution

K990703510(k) SpecialCleared Mar 30, 199926-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

Reckitt Benckiser, Inc. · MED Sterilant, Medical Devices

Cleared on Mar 30, 1999 as substantially equivalent to K970230 (Reckitt Benckiser, Inc., 1997) after a 26-day review. Its family tree reaches back 2 generations to 1994.

Decided: Mar 30, 1999
Review: 26 days
Class: Class II
Product code: MED
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K924334 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK924334 Cidex Formula 7* Long-Life Activated DialdehydeJohnson & Johnson Medical, Inc. · 1994
1 generation backK970230 SporoxReckitt Benckiser, Inc. · 1997
This deviceK990703 Sporox II Sterilizing & Disinfecting SolutionReckitt Benckiser, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K924334	Cidex Formula 7* Long-Life Activated Dialdehyde	Johnson & Johnson Medical, Inc.	1994	—
−1	K970230	Sporox	Reckitt Benckiser, Inc.	1997	—
0 (this device)	K990703	Sporox II Sterilizing & Disinfecting Solution	Reckitt Benckiser, Inc.	1999	—

FIG. 1 — Lineage of K990703, 1994–1999Source: 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
*	K970230	Sporox Summary page 1 …rilant / High Level Disinfectant (MED) Unclassified (proposed class II) Predicate Device: The predicate device is SPOROX® Sterilizing & Disinfecting Solution 510(k) #- K970230 (1997) Marketed by Reckitt & Colman Inc. Description of Device SPOROX® II is a nominal 7.5% hydrogen peroxide solution, buffere…	Reckitt Benckiser, Inc.	1997	—

Also cleared against K970230: 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?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K970230.

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?

SPOROX® II Sterilizing & Disinfecting Solution is a ready to use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. SPOROX II® Sterilizing & Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20°C to high level disinfect. SPOROX II® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990703: Sporox II Sterilizing & Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990703

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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