510(k) · Cleared

Cleared

Copan Venturi Transystem Amies Medium Without Charcoal

K972448510(k) TraditionalCleared Aug 20, 199751-day reviewClass I21 CFR 866.2390

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Copan Italia Spa · JSL Culture Media, Anaerobic Transport

Cleared on Aug 20, 1997 as substantially equivalent to K960997 (Starplex Scientific, Inc., 1996) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1986. 6 later devices descend from it.

Decided: Aug 20, 1997
Review: 51 days
Class: Class I
Product code: JSL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K854986 (1986). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK854986 BBL Port-a-Cul Aerobic Transport Sys, Modified StuBd Becton Dickinson Vacutainer Systems Preanalytic · 1986
This deviceK972448 Copan Venturi Transystem Amies Medium Without CharcoalCopan Italia Spa · 1997
Descendant · cites it directly · 4 of its ownK061301 Copan Liquid Amies Elution Swab (Eswab) Collection and Transport…Copan Diagnostics, Inc. · 2006
Descendant · 2 generations on · 1 of its ownK120846 Transport Culture Medium DevicePuritan Medical Products, LLC · 2012
Descendant · 2 generations on · 1 of its ownK121039 Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
Descendant · 3 generations on · 0 of its ownK222613 ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024
Descendant · 3 generations on · 0 of its ownK211707 BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006high 2 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all

K061301Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemCopan Diagnostics, Inc. · 2006 · cites it directly4descendants
K120846Transport Culture Medium DevicePuritan Medical Products, LLC · 2012 · 2 generations on1descendant
K121039Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012 · 2 generations on1descendant
K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. · 2024 · 3 generations on0descendants
K211707BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd. · 2022 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K854986	BBL Port-a-Cul Aerobic Transport Sys, Modified Stu	Bd Becton Dickinson Vacutainer Systems Preanalytic	1986	—
0 (this device)	K972448	Copan Venturi Transystem Amies Medium Without Charcoal	Copan Italia Spa	1997	—
+1	K061301	Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System	Copan Diagnostics, Inc.	2006	—
+2	K120846	Transport Culture Medium Device	Puritan Medical Products, LLC	2012	—
+2	K121039	Copan Mswab Collection, Transport and Preservation System	Copan Flock Technologies	2012	—
+3	K222613	ARX Liquid Amies Collection & Transport System	Arx Sciences, Inc.	2024	—
+3	K211707	BioTeke Sterile Disposable Virus Sampling Kit	Bioteke Corporation (Wuxi) Co., Ltd.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2012	2	0
2013	1	0
2022	1	0
2024	1	0

FIG. 1 — Lineage of K972448, 1986–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JSL? 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

Get a 510(k) Report

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	Applicant	Decided	Recalls
*	K960997	Starswab Culture Collection and Transport System Summary page 1 …l Specimen Collection and Transport Device Classification Status: Class I 3. Predicate Devices -« Starswab Culture Collection and Transport System Starplex Scientific K960997 o Port-A-Cul Specimen Collection and Transport Products Becton Dickinson K854986 Copan Diagnostics Inc. Amies Medium Without C…	Starplex Scientific, Inc.	1996	—
*	K854986	BBL Port-a-Cul Aerobic Transport Sys, Modified Stu Summary page 1 …icate Devices -« Starswab Culture Collection and Transport System Starplex Scientific K960997 o Port-A-Cul Specimen Collection and Transport Products Becton Dickinson K854986 Copan Diagnostics Inc. Amies Medium Without Charcoal 510(k) 6/27/97 Page F-1 4. Device Description The Copan Ve…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1986	—

Also cleared against K960997: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061301	Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System	Copan Diagnostics, Inc.	2006	4
K131630	Puritan Amies Medium Collection and Transport System	Puritan Medical Products, LLC	2013	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K061301 (Copan Diagnostics, Inc., 2006) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K960997.

How does its category compare?

All JSL devices

JSL Culture Media, Anaerobic Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSL

FDA has decided no JSL device since 2007.

Median 510(k) review, days · JSL

Too few JSL 510(k)s in any year since 2007 to give a median.

Recalls per year · JSL

No recall names JSL since 2007.

Adverse event reports per year · JSL

1in 2023

2007high 7 (2018) · low 0 (2010)2025

MAUDE reports naming product code JSL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
2008	—	1
2009	—	5
2010	—	0
2011	—	0
2012	—	1
2013	—	1
2014	—	1
2015	—	0
2016	—	0
2017	—	0
2018	—	7
2019	—	3
2020	—	5
2021	—	2
2022	—	2
2023	—	1
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Copan Venturi Transystem Amies Medium Without Charcoal products are sterile, single-use specimen collection chambers intended to preserve the viability of microorganisms after their collection and during their transport from the collecting area to the laboratory. These devices are intended for the collection, transport, and preservation of clinical specimens for bacteriological examination. Copan Venturi Transystem Amies Medium Without Charcoal is designed to support the viability of a wide variety of clinically important aerobic and anaerobic bacteria.

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/K972448 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972448: Copan Venturi Transystem Amies Medium Without Charcoal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972448

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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