510(k) · Cleared
ClearedPuritan Amies Medium Collection and Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Medical Products, LLC · LIO Device, Specimen Collection
Cleared on Oct 21, 2013 as substantially equivalent to K972448 (Copan Italia Spa, 1997) after a 139-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Oct 21, 2013
- Review
- 139 days
- Class
- Class I
- Product code
- LIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854986 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK854986 BBL Port-a-Cul Aerobic Transport Sys, Modified StuBd Becton Dickinson Vacutainer Systems Preanalytic · 1986
- 1 generation backK972448 Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997
- This deviceK131630 Puritan Amies Medium Collection and Transport SystemPuritan Medical Products, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854986 | BBL Port-a-Cul Aerobic Transport Sys, Modified Stu | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986 | — |
| −1 | K972448 | Copan Venturi Transystem Amies Medium Without Charcoal | Copan Italia Spa | 1997 | — |
| 0 (this device) | K131630 | Puritan Amies Medium Collection and Transport System | Puritan Medical Products, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K972448 | Copan Venturi Transystem Amies Medium Without CharcoalSummary page 1…Microbiology 5.4 Predicate Device BID CultureSwabM Collection and Transport System manufactured by Copan Diagnostics Inc. of Italy 510K Number: K972448 5.5 Device Description Puritan Amies Medium Collection and Transport System is comprised of a ster… | 1997 |
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 27 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K972448.
How does its category compare?
All LIO devicesLIO Device, Specimen Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131630: Puritan Amies Medium Collection and 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/K131630
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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