510(k) · Cleared
ClearedARX Liquid Amies Collection & Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arx Sciences, Inc. · LIO Device, Specimen Collection
Cleared on Mar 27, 2024 as substantially equivalent to K120846 (Puritan Medical Products, LLC, 2012) after a 575-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Mar 27, 2024
- Review
- 575 days
- Class
- Class I
- Product code
- LIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854986 (1986). 6 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 backK120846 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
- This deviceK222613 ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024
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 | K120846 | Transport Culture Medium Device | Puritan Medical Products, LLC | 2012 | — |
| 0 (this device) | K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K120846 | Transport Culture Medium DeviceSummary page 4…JTW: System, Transport, Aerobic JTX: Transport Systems, Anaerobic Predicate Device: K120846 Transport Culture Medium Device Puritan Medical Products LLC. Device Description: The ARX… | 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 38 years and passes through 5 companies; a new generation was cleared every 11.6 years on median.
- None of the 6 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. 2024, 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?
The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, anaerobic, and fastidious bacteria and their transport at 2-80 C or 25-30 0 C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.
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/K222613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222613: ARX Liquid Amies Collection & Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222613
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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