510(k) · Cleared
ClearedEnsol EnTM Specimen Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ensol Biosciences, Inc. · JSM Culture Media, Non-Propagating Transport
Cleared on Aug 29, 2024 as substantially equivalent to K042970 (Copan Diagnostics, Inc., 2004) after an 884-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 29, 2024
- Review
- 884 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910526 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K042970 | Copan Universal Transport Medium (Utm-RT) SystemSummary page 6…gnostic/identification techniques that utilize stable recoverable infectious viral particles. Predicate Device: Copan Universal Transport Medium (UTM-RT) System (K042970) by COPAN DIAGNOSTICS, INC. Substantial Equivalence: The subject and predicate devices comparison is described in the table… | 2004 |
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 33 years and passes through 3 companies; a new generation was cleared every 19.7 years on median.
- None of the 2 ancestors has a recall.
- 13 other devices also cite its predicate K042970.
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. 2024, 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 Ensol EnTM Collection and Transport System is intended for the collection and transportation of clinical samples
containing upper respiratory viruses including Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus
(RSV) from the collection site to the testing laboratory to be used with standard diagnostic/identification techniques that
utilize stable recoverable infectious viral particles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220908: Ensol EnTM Specimen Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220908
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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