510(k) · Cleared
ClearedVirocult, Model MW950
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Wire & Equipment Company (Bath), Ltd. · LIO Device, Specimen Collection
Cleared on Dec 30, 2008 as substantially equivalent to K800832 (Marion Health & Safety, Inc., 1980) and 1 other predicate after a 124-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Dec 30, 2008
- Review
- 124 days
- Class
- Class I
- Product code
- LIO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K800832 (1980). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK800832 Viral Culturette Hank's Bal. Salt Sol.Marion Health & Safety, Inc. · 1980
- This deviceK082472 Virocult, Model MW950Medical Wire & Equipment Company (Bath), Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800832 | Viral Culturette Hank's Bal. Salt Sol. | Marion Health & Safety, Inc. | 1980 | — |
| 0 (this device) | K082472 | Virocult, Model MW950 | Medical Wire & Equipment Company (Bath), Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 LIO? 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 LIO device
- #1 K222613 ARX Liquid Amies Collection & Transport Systemscore 8.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K800832 | Viral Culturette Hank's Bal. Salt Sol.Summary page 1…Specimen collection and transport device 3. Predicate Devices Becton Dickinson Viral Culturette T M (K800832) Copan Viral Transystem TM (KO01780) 4. Device Description Each Virocult® device… | 1980 |
| * | K001780 | Copan Viral TransystemSummary page 2…llection and transport of viruses. Specifically Virocult® products are equivalent to the Becton Dickinson Viral Culturette (K800832), and the the Copan Viral Transystem (K001780). Medical Wire & Equipment's Virocult® device, and the substantially equivalent products are all sterile, single use devices int… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LIO devicesLIO Device, Specimen Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LIO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIO
Too few LIO 510(k)s in any year since 2007 to give a median.
Recalls per year · LIO
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIO
6in 2025
MAUDE reports naming product code LIO, 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 | 8 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 1 | 3 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082472: Virocult, Model MW950.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082472
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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