510(k) · Cleared
ClearedSporox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reckitt Benckiser, Inc. · MED Sterilant, Medical Devices
Cleared on Oct 29, 1997 as substantially equivalent to K924334 (Johnson & Johnson Medical, Inc., 1994) after a 281-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.
- Decided
- Oct 29, 1997
- Review
- 281 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924334 (1994). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK924334 Cidex Formula 7* Long-Life Activated DialdehydeJohnson & Johnson Medical, Inc. · 1994
- This deviceK970230 SporoxReckitt Benckiser, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK103059 TrophonNanosonics Limited · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK173865 trophon2Nanosonics Limited · 2018
- Descendant · cites it directly · 1 of its ownK080420 Resert XL HLD High Level DisinfectantSTERIS Corporation · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK250434 trophon2Nanosonics · 2025
- Descendant · 3 generations on · 0 of its ownK241536 trophon Wireless Ultrasound Probe HolderNanosonics Limited · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K103059TrophonNanosonics Limited · 2011 · cites it directly3descendants
- K173865trophon2Nanosonics Limited · 2018 · 2 generations on2descendants
- K080420Resert XL HLD High Level DisinfectantSTERIS Corporation · 2008 · cites it directly1descendant
- K250434trophon2Nanosonics · 2025 · 3 generations on0descendants
- K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924334 | Cidex Formula 7* Long-Life Activated Dialdehyde | Johnson & Johnson Medical, Inc. | 1994 | — |
| 0 (this device) | K970230 | Sporox | Reckitt Benckiser, Inc. | 1997 | — |
| +1 | K103059 | Trophon | Nanosonics Limited | 2011 | 1 |
| +2 | K173865 | trophon2 | Nanosonics Limited | 2018 | — |
| +1 | K080420 | Resert XL HLD High Level Disinfectant | STERIS Corporation | 2008 | 1 |
| +3 | K250434 | trophon2 | Nanosonics | 2025 | — |
| +3 | K241536 | trophon Wireless Ultrasound Probe Holder | Nanosonics Limited | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K924334 | Cidex Formula 7* Long-Life Activated DialdehydeSummary page 1…rilant / high level disinfectant (MED) Unclassified 3.0 Predicate Device: Cidex’ Formula 7 Long-Life Activated Dialdehyde Solution, manufactured by Jotinson & Johnson (K924334), Section 4 - 1 OCT.24.1997 3:41PM FECKITT & COLMAN TECH CTR. NUL L FLoged 4.0 5.0 6.0 RECKITT & COLMAN INC… | 1994 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 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® 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® Sterilizing and 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® 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/K970230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970230: Sporox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970230
Report an extraction error
Are you the manufacturer?
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