510(k) · Cleared
ClearedCulture Collection and Transport System, Modified Amies Media
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Packaging Corp. · JSM Culture Media, Non-Propagating Transport
Cleared on Dec 24, 1996 as substantially equivalent to K881105 (Medical Packaging Corp., 1988) and 2 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Dec 24, 1996
- Review
- 35 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K881105 (1988). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK881105 Culture Collection DeviceMedical Packaging Corp. · 1988
- This deviceK964637 Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp. · 1996
- Descendant · cites it directly · 1 of its ownK970597 Culture-Pak Collection and Transport System with Clinical Transport…Medical Packaging Corp. · 1997
- Descendant · cites it directly · 0 of its ownK972726 Snap Swab Culture Collection and Transport SystemMedical Packaging Corp. · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881105 | Culture Collection Device | Medical Packaging Corp. | 1988 | — |
| 0 (this device) | K964637 | Culture Collection and Transport System, Modified Amies Media | Medical Packaging Corp. | 1996 | — |
| +1 | K970597 | Culture-Pak Collection and Transport System with Clinical Transport Media… | Medical Packaging Corp. | 1997 | — |
| +1 | K972726 | Snap Swab Culture Collection and Transport System | Medical Packaging Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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 JSM? 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 JSM device
- #1 K242976 Medical Wire Fecal Transwab Liquid Cary Blair…score 10.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K881105 | Culture Collection DeviceSummary page 1…ICATION: Class I, General Controls COMMON NAME: Microbiological specimen collection and transport device PREDICATE DEVICE(S): Culture Collection and Transport Device (K881105), CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K932337/S1 and K936078 ) Medical Packaging Corporation… | 1988 |
| * | K932337 | Culture-Pak Collection and Transport SystemSummary page 1…ion and transport device PREDICATE DEVICE(S): Culture Collection and Transport Device (K881105), CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K932337/S1 and K936078 ) Medical Packaging Corporation Camarillo, CA Intended Use Medical Packaging Corporation's CULTURE-PAK™ Collect… | 1994 |
| * | K936078 | Culture-Pak Collection/Transport System, ModifiedSummary page 1…rt device PREDICATE DEVICE(S): Culture Collection and Transport Device (K881105), CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K932337/S1 and K936078 ) Medical Packaging Corporation Camarillo, CA Intended Use Medical Packaging Corporation's CULTURE-PAK™ Collection and Transpo… | 1994 |
What descends from it? (2)
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K970597 (Medical Packaging Corp., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JSM devicesJSM Culture Media, Non-Propagating Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JSM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JSM
241in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JSM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSM
63in 2025
MAUDE reports naming product code JSM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 4 | 195 | 0 | 1 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 57 |
| 2018 | 1 | — | 0 | 131 |
| 2019 | 0 | — | 0 | 81 |
| 2020 | 0 | — | 4 | 47 |
| 2021 | 1 | — | 1 | 42 |
| 2022 | 5 | 344 | 1 | 36 |
| 2023 | 3 | 254 | 0 | 48 |
| 2024 | 9 | 271 | 0 | 21 |
| 2025 | 3 | 241 | 0 | 63 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.
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/K964637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964637: Culture Collection and Transport System, Modified Amies Media.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964637
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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