510(k) · Cleared
ClearedMedivators 5 Minute High-Level Disinfectant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivators, Inc. · MED Sterilant, Medical Devices
Cleared on Aug 17, 2000 after a 342-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Aug 17, 2000
- Review
- 342 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK993042 Medivators 5 Minute High-Level DisinfectantMedivators, Inc. · 2000
- Descendant · cites it directly · 9 of its ownK051305 CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100…Cs Medical, LLC · 2005
- Descendant · cites it directly · 3 of its ownK120306 Rapicide Opa-28Minntech Corp. · 2012
- Descendant · 2 generations on · 3 of its ownK103059 TrophonNanosonics Limited · 2011 · Recalled
- Descendant · 3 generations on · 2 of its ownK173865 trophon2Nanosonics Limited · 2018
- Descendant · 2 generations on · 2 of its ownK160921 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level…Cs Medical, LLC · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5…Cs Medical, LLC · 2005 · cites it directly9descendants
- K120306Rapicide Opa-28Minntech Corp. · 2012 · cites it directly3descendants
- K103059TrophonNanosonics Limited · 2011 · 2 generations on3descendants
- K173865trophon2Nanosonics Limited · 2018 · 3 generations on2descendants
- K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical…Cs Medical, LLC · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993042 | Medivators 5 Minute High-Level Disinfectant | Medivators, Inc. | 2000 | — |
| +1 | K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical… | Cs Medical, LLC | 2005 | — |
| +1 | K120306 | Rapicide Opa-28 | Minntech Corp. | 2012 | — |
| +2 | K103059 | Trophon | Nanosonics Limited | 2011 | 1 |
| +3 | K173865 | trophon2 | Nanosonics Limited | 2018 | — |
| +2 | K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS… | Cs Medical, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | Wavicide-01 Solution Named without a submission number |
What descends from it? (11)
See all 112 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?
- Of its descendants, K051305 (Cs Medical, LLC, 2005) has gone furthest, with 9 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?
Refer to the package nsert for mare detailed information about product ysage, matenal compatbility, and other subjects. STERILIZATION: Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated sterilization of clean, heat sensitive, critical medical equipment for which alternative methods of sterilization are not suitable. Critical medical devices are those that contact normally sterile areas of the body. Critical medical…
Read the full statement (238 words)
Refer to the package nsert for mare detailed information about product ysage, matenal compatbility, and other subjects.
STERILIZATION:
Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated sterilization of clean, heat sensitive, critical medical equipment for which alternative methods of sterilization are not suitable. Critical medical devices are those that contact normally sterile areas of the body. Critical medical devices must be sterilized.
Rapicide™ High Level Disinfectant and Sterilant is a sterilant when used or reused, in a legally marketed Automated Endoscope Reprocessor according 1o Directions for Use, at @ minimum recommended concentratian (MRC) of 1.5% glutaraldehyde at 35°C (95°F), not to exceed 28 days, with @ minimum coniact or immersion time of at least 7 hours and 40 minutes.
HIGH-LEVEL DISINFECTION:
Rapiciae™ High Level Disinfectant and Sterilant is intended to be used for the autormnated high level disinfection of clean, heat sensitive, semi-critical medical devices for which sterilization is not practical. Semi-cntical medical devices may be sterilized or high-level disinfected. Semi-critical medical devices are those that contact mucous membranes or ather body surfaces not normally considered sterile.
Rapicide™ High Level Disinfectant and Sterilant is a high-level disinfectant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended concentration (MRC) of 1.5% glutaraldehyde at 35°C (35°F), not to exceed 28 days, with a minimum contact or immersion tme of at least 5 minutes.
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/K993042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993042: Medivators 5 Minute High-Level Disinfectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993042
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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