510(k) · Cleared
ClearedEndo-Spor Plus / Hyprocide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cottrell, Ltd. · MED Sterilant, Medical Devices
Cleared on Sep 13, 1999 as substantially equivalent to K932922 (Cottrell, Ltd., 1995) and 4 other predicates after a 784-day review. Its family tree reaches back 1 generation to 1988. 7 later devices descend from it.
- Decided
- Sep 13, 1999
- Review
- 784 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K875280 (1988). 5 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK875280 Steris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc. · 1988 · Recalled
- This deviceK972708 Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999
- Descendant · cites it directly · 6 of its ownK013280 Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK090036 System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK101409 System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 3 generations on · 2 of its ownK102462 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK113520 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2012 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002 · cites it directly6descendants
- K090036System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · 2 generations on4descendants
- K101409System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · 3 generations on3descendants
- K102462System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · 3 generations on2descendants
- K113520System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2012 · 3 generations on1descendant
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) | K972708 | Endo-Spor Plus / Hyprocide | Cottrell, Ltd. | 1999 | — |
| +1 | K013280 | Sterilox Liquid Chemical Sterilant System | Sterilox Technologies, Inc. | 2002 | — |
| +2 | K090036 | System 1.5 Sterile Processing System | STERIS Corporation | 2010 | 6 |
| +3 | K101409 | System IE Liquid Chemical Cterilant Processing System | STERIS Corporation | 2010 | 4 |
| +3 | K102462 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2010 | 5 |
| +3 | K113520 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K932922 | Procide 14 N.S., Omnicide/Liquid & Plus Liq ActivatorSummary page 1…Common/Usual Name: Liquid Chemical Germicide Classification Name: Liquid Chemical Germicide 3. PREDICATE DEVICES Omnicide and Procide 14 N.S. sterilants/disinfectants (K932922), manufactured by Cottrell, Ltd.; Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434), manufactured by Joh… | 1995 |
| * | K923744 | Cidex Plus 28 Day SolutionSummary page 1…e 3. PREDICATE DEVICES Omnicide and Procide 14 N.S. sterilants/disinfectants (K932922), manufactured by Cottrell, Ltd.; Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434), manufactured by Johnson & Johnson; STERIS 20 (K875250), manufactured by STERIS Corporation. 4. INTENDED USE… | 1994 |
| * | K924334 | Cidex Formula 7* Long-Life Activated DialdehydeSummary page 1…DICATE DEVICES Omnicide and Procide 14 N.S. sterilants/disinfectants (K932922), manufactured by Cottrell, Ltd.; Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434), manufactured by Johnson & Johnson; STERIS 20 (K875250), manufactured by STERIS Corporation. 4. INTENDED USE Endo-Spo… | 1994 |
| * | K924434 | Cidex Activated Dialdehyde SolutionSummary page 1…VICES Omnicide and Procide 14 N.S. sterilants/disinfectants (K932922), manufactured by Cottrell, Ltd.; Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434), manufactured by Johnson & Johnson; STERIS 20 (K875250), manufactured by STERIS Corporation. 4. INTENDED USE Endo-Spor Plus™ l… | 1994 |
| * | K875280 | Steris System 1 Processor and 20 Sterilant Our OCR of the scanned summary read K875250, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. | 1988 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013280 | Sterilox Liquid Chemical Sterilant System | 2002 | 6 |
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 5 ancestors has a recall of any class.
- Of its descendants, K013280 (Sterilox Technologies, Inc., 2002) has gone furthest, with 6 descendants of its own.
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?
Endo-Spor Plus™/Hyprocide™ is a chemical disinfecting and sterilization solution for use on flexible lensed endoscopy instruments, inhalation therapy equipment and instruments and materials that cannot be heat sterilized.
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/K972708 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972708: Endo-Spor Plus / Hyprocide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972708
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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