510(k) · Cleared
ClearedCoproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diesse Diagnostica Senese S.P.A. · LIO Device, Specimen Collection
Cleared on Jul 30, 2007 as substantially equivalent to K781304 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1978) and 1 other predicate after a 206-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Jul 30, 2007
- Review
- 206 days
- Class
- Class I
- Product code
- LIO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K781304 (1978). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK781304 Transport MediaBd Becton Dickinson Vacutainer Systems Preanalytic · 1978
- This deviceK070062 Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab…Diesse Diagnostica Senese S.P.A. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781304 | Transport Media | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978 | — |
| 0 (this device) | K070062 | Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set… | Diesse Diagnostica Senese S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K781304 | Transport MediaSummary page 3…Eugon Broth Kits Predicate K781304 K781304 K024240 K781304 Device 510(k) Product Code… | 1978 |
| * | K024240 | BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and KitsSummary page 3…Kits Predicate K781304 K781304 K024240 K781304 Device 510(k) Product Code JSN JSN… | 2003 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LIO devicesLIO Device, Specimen Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp. In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp Disposable in vitro diagnostic device for the…
Read the full statement (125 words)
In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp.
In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp
Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory.
Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070062: Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070062
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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