510(k) · Cleared
ClearedPeract 20 Liquid Sterilant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minntech Corp. · MED Sterilant, Medical Devices
Cleared on Oct 1, 1997 after a 604-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Oct 1, 1997
- Review
- 604 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK960513 Peract 20 Liquid SterilantMinntech Corp. · 1997
- Descendant · cites it directly · 7 of its ownK082988 Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA…Medivators Reprocessing Systems · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK152394 Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK251035 DISINTEK™ PA Test StripsSerim Research · 2025
- Descendant · 3 generations on · 0 of its ownK251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems · 2009 · cites it directly7descendants
- K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016 · 2 generations on2descendants
- K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC · 2020 · 2 generations on1descendant
- K251035DISINTEK™ PA Test StripsSerim Research · 2025 · 3 generations on0descendants
- K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960513 | Peract 20 Liquid Sterilant | Minntech Corp. | 1997 | — |
| +1 | K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High… | Medivators Reprocessing Systems | 2009 | 4 |
| +2 | K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016 | — |
| +2 | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical… | Cs Medical, LLC | 2020 | — |
| +3 | K251035 | DISINTEK™ PA Test Strips | Serim Research | 2025 | — |
| +3 | K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | — | Cottrell’s ProCide® NS Named without a submission number | |
| * | — | Johnson & Johnson’s Cidex® Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082988 | Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level… | 2009 | 7 |
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?
- Of its descendants, K082988 (Medivators Reprocessing Systems, 2009) has gone furthest, with 7 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?
Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion. Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored. Peract™ 20 Liquid Sterilant/Disinfectant should be used under…
Read the full statement (107 words)
Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.
Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.
Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions:
Sterilization: 8 hours, 68°F (20°C), 500 ppm peracetic acid.
High Level Disinfection: 25 minutes, 68°F (20°C), 500 ppm peracetic acid.
Peract™ 20 Indicator Test Strips are intended for verifying the minimum effective concentration of peracetic acid in Peract™ 20 Liquid Sterilant/Disinfectant during reuse.
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/K960513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960513: Peract 20 Liquid Sterilant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960513
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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