510(k) · Cleared
ClearedCulture-Pak Collection/Transport System, Modified
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 Aug 16, 1994 after a 326-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 16, 1994
- Review
- 326 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK936078 Culture-Pak Collection/Transport System, ModifiedMedical Packaging Corp. · 1994
- Descendant · cites it directly · 2 of its ownK964637 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 3 of 3 · See all- K964637Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp. · 1996 · cites it directly2descendants
- K970597Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair…Medical Packaging Corp. · 1997 · cites it directly1descendant
- K972726Snap Swab Culture Collection and Transport SystemMedical Packaging Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936078 | Culture-Pak Collection/Transport System, Modified | Medical Packaging Corp. | 1994 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 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, K964637 (Medical Packaging Corp., 1996) has gone furthest, with 2 descendants 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 | — |
https://510kreport.com/device/K936078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936078: Culture-Pak Collection/Transport System, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936078
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026