510(k) · Cleared
ClearedBioTeke Sterile Disposable Virus Sampling Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteke Corporation (Wuxi) Co., Ltd. · JSM Culture Media, Non-Propagating Transport
Cleared on May 4, 2022 as substantially equivalent to K113249 (Puritan Medical Products, LLC, 2012) and 1 other predicate after a 335-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- May 4, 2022
- Review
- 335 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K854986 (1986). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK854986 BBL Port-a-Cul Aerobic Transport Sys, Modified StuBd Becton Dickinson Vacutainer Systems Preanalytic · 1986
- 3 generations backK972448 Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997
- 2 generations backK061301 Copan Liquid Amies Elution Swab (Eswab) Collection and Transport…Copan Diagnostics, Inc. · 2006
- 1 generation backK121039 Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
- This deviceK211707 BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854986 | BBL Port-a-Cul Aerobic Transport Sys, Modified Stu | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986 | — |
| −3 | K972448 | Copan Venturi Transystem Amies Medium Without Charcoal | Copan Italia Spa | 1997 | — |
| −2 | K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System | Copan Diagnostics, Inc. | 2006 | — |
| −1 | K121039 | Copan Mswab Collection, Transport and Preservation System | Copan Flock Technologies | 2012 | — |
| 0 (this device) | K211707 | BioTeke Sterile Disposable Virus Sampling Kit | Bioteke Corporation (Wuxi) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 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 JSM? 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 JSM device
- #1 K242976 Medical Wire Fecal Transwab Liquid Cary Blair…score 10.7 · 2 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 |
|---|---|---|---|
| * | K113249 | Transport Culture Medium DeviceSummary page 6…Sterile Disposable Virus Sampling Swab Kit shares indications and design principles with the following predicate devices: Puritan UTM-RT Collection and Transport System (K113249) and the Copan MSwab™ Collection, Preservation and Transport System (K121039); a Class I medical devices that were cleared for ma… | 2012 |
| * | K121039 | Copan Mswab Collection, Transport and Preservation SystemSummary page 6…ciples with the following predicate devices: Puritan UTM-RT Collection and Transport System (K113249) and the Copan MSwab™ Collection, Preservation and Transport System (K121039); a Class I medical devices that were cleared for marketing in the United States under K113249 and K121039, respectively. The Bi… | 2012 |
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?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 9.9 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K113249.
How does its category compare?
All JSM devicesJSM Culture Media, Non-Propagating Transport: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JSM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JSM
241in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JSM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSM
63in 2025
MAUDE reports naming product code JSM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 4 | 195 | 0 | 1 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 57 |
| 2018 | 1 | — | 0 | 131 |
| 2019 | 0 | — | 0 | 81 |
| 2020 | 0 | — | 4 | 47 |
| 2021 | 1 | — | 1 | 42 |
| 2022 | 5 | 344 | 1 | 36 |
| 2023 | 3 | 254 | 0 | 48 |
| 2024 | 9 | 271 | 0 | 21 |
| 2025 | 3 | 241 | 0 | 63 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioTeke Sterile Disposable Virus Sampling Kit is intended for the collection and transport of clinical specimens to
the laboratory for standard diagnostic / identification techniques. The BioTeke Sterile Disposable Virus Sampling Kit
consists of a sterile swab and culture-based media that can be used for respiratory viral diagnostic assays including,
Influenza, Respiratory Syncytial Virus (RSV) A and B, Parainfluenza, Adenovirus, and Rhinovirus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211707 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211707: BioTeke Sterile Disposable Virus Sampling Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211707
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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