510(k) · Cleared
ClearedViragard/Virashield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tri-Med, Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Jun 16, 1982 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 16, 1982
- Review
- 117 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK820459 Viragard/VirashieldTri-Med, Inc. · 1982
- Descendant · cites it directly · 2 of its ownK983076 Medisystems Transducer ProtectorMedisystems Corp. · 1998
- Descendant · 2 generations on · 1 of its ownK072988 Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008
- Descendant · 3 generations on · 0 of its ownK240164 NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K983076Medisystems Transducer ProtectorMedisystems Corp. · 1998 · cites it directly2descendants
- K072988Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008 · 2 generations on1descendant
- K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820459 | Viragard/Virashield | Tri-Med, Inc. | 1982 | — |
| +1 | K983076 | Medisystems Transducer Protector | Medisystems Corp. | 1998 | — |
| +2 | K072988 | Nipro Transducer Protector TP-Sure, Model Tpsure+1 | Nipro Medical Corporation | 2008 | — |
| +3 | K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
| 2024 | 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 DRS? 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 DRS device
- #1 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ…score 17.4 · 29 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983076 | Medisystems Transducer Protector | 1998 | 2 |
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, K983076 (Medisystems Corp., 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRS
186in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRS
15in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DRS
187in 2025
MAUDE reports naming product code DRS, 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 | 1 | — | 0 | 397 |
| 2008 | 0 | — | 0 | 531 |
| 2009 | 2 | — | 0 | 344 |
| 2010 | 2 | — | 0 | 115 |
| 2011 | 3 | 135 | 0 | 63 |
| 2012 | 1 | — | 0 | 43 |
| 2013 | 1 | — | 0 | 39 |
| 2014 | 1 | — | 0 | 23 |
| 2015 | 1 | — | 0 | 60 |
| 2016 | 3 | 186 | 162 | 89 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 0 | — | 11 | 82 |
| 2019 | 0 | — | 0 | 84 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 93 |
| 2022 | 0 | — | 0 | 95 |
| 2023 | 1 | — | 15 | 147 |
| 2024 | 0 | — | 0 | 205 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 1 | — | 2 (2) | — |
https://510kreport.com/device/K820459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820459: Viragard/Virashield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820459
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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