510(k) · Cleared
ClearedCulture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option)
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 Mar 24, 1997 as substantially equivalent to K932337 (Medical Packaging Corp., 1994) and 2 other predicates after a 34-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Mar 24, 1997
- Review
- 34 days
- Class
- Class I
- Product code
- JSM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K881105 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK881105 Culture Collection DeviceMedical Packaging Corp. · 1988
- 1 generation backK964637 Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp. · 1996
- This deviceK970597 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K881105 | Culture Collection Device | Medical Packaging Corp. | 1988 | — |
| −1 | K964637 | Culture Collection and Transport System, Modified Amies Media | Medical Packaging Corp. | 1996 | — |
| 0 (this device) | 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 | 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 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 |
|---|---|---|---|
| * | K932337 | Culture-Pak Collection and Transport SystemSummary page 1…) DEVICE CLASSIFICATION: Class I, General Controls COMMON NAME: Microbiological specimen collection and transport device PREDICATE DEVICE(S): Modified Stuart's Media (K932337/S1 and K936078 ), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637. Medical Packaging Co… | 1994 |
| * | K936078 | Culture-Pak Collection/Transport System, ModifiedSummary page 1…IFICATION: Class I, General Controls COMMON NAME: Microbiological specimen collection and transport device PREDICATE DEVICE(S): Modified Stuart's Media (K932337/S1 and K936078 ), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637. Medical Packaging Corporation Camar… | 1994 |
| * | K964637 | Culture Collection and Transport System, Modified Amies MediaSummary page 1…ansport device PREDICATE DEVICE(S): Modified Stuart's Media (K932337/S1 and K936078 ), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637. Medical Packaging Corporation Camarillo, CA Intended Use Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972726 | Snap Swab Culture Collection and Transport System | 1997 | 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?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 8.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K972726 (Medical Packaging Corp., 1997) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K932337.
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 Clinical Transport Media, (Cary-Blair Transport Media Option) 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/K970597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970597: Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970597
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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