510(k) · Cleared
ClearedWavicide (R) -01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wave Energy Systems, Inc. · MED Sterilant, Medical Devices
Cleared on Aug 10, 1995 after a 1,388-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Aug 10, 1995
- Review
- 1,388 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK914749 Wavicide (R) -01Wave Energy Systems, Inc. · 1995
- Descendant · cites it directly · 9 of its ownK051305 CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100…Cs Medical, LLC · 2005
- 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
- Descendant · 3 generations on · 1 of its ownK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5…Cs Medical, LLC · 2005 · cites it directly9descendants
- 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
- K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914749 | Wavicide (R) -01 | Wave Energy Systems, Inc. | 1995 | — |
| +1 | K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical… | Cs Medical, LLC | 2005 | — |
| +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 | — |
| +3 | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical… | Cs Medical, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5… | 2005 | 9 |
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 | — |
https://510kreport.com/device/K914749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K914749: Wavicide (R) -01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914749
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026