510(k) · Cleared
ClearedStarswab Culture Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starplex Scientific, Inc. · LIO Device, Specimen Collection
Cleared on Apr 3, 1996 after a 22-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Apr 3, 1996
- Review
- 22 days
- Class
- Class I
- Product code
- LIO
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK960997 Starswab Culture Collection and Transport SystemStarplex Scientific, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK972448 Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997
- Descendant · 2 generations on · 4 of its ownK061301 Copan Liquid Amies Elution Swab (Eswab) Collection and Transport…Copan Diagnostics, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK120846 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK121039 Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
- Descendant · 4 generations on · 0 of its ownK222613 ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K972448Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997 · cites it directly6descendants
- K061301Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemCopan Diagnostics, Inc. · 2006 · 2 generations on4descendants
- K120846Transport Culture Medium DevicePuritan Medical Products, LLC · 2012 · 3 generations on1descendant
- K121039Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012 · 3 generations on1descendant
- K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960997 | Starswab Culture Collection and Transport System | Starplex Scientific, Inc. | 1996 | — |
| +1 | 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 | — |
| +3 | K120846 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| +3 | K121039 | Copan Mswab Collection, Transport and Preservation System | Copan Flock Technologies | 2012 | — |
| +4 | K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2006 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | Amies CultureSwab™ Transport Systems with and without charcoal Named without a submission number |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K972448 (Copan Italia Spa, 1997) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LIO devicesLIO Device, Specimen Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Starswab Culture Collection and Transport System is self-contained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960997 · printed Nov 3, 2026
Cite this page
510(k) Report. “K960997: Starswab Culture Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K960997
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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