510(k) Report

510(k) · Cleared

Cleared

Culture-Pak Collection and Transport System

K932337510(k) TraditionalCleared Aug 16, 1994459-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

Medical Packaging Corp. · JSM Culture Media, Non-Propagating Transport

Cleared on Aug 16, 1994 after a 459-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
459 days
Class
Class I
Product code
JSM
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 2 descendants cleared1990200020102020
  1. This deviceK932337 Culture-Pak Collection and Transport SystemMedical Packaging Corp. · 1994
  2. Descendant · cites it directly · 2 of its ownK964637 Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp. · 1996
  3. Descendant · cites it directly · 1 of its ownK970597 Culture-Pak Collection and Transport System with Clinical Transport…Medical Packaging Corp. · 1997
  4. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932337Culture-Pak Collection and Transport SystemMedical Packaging Corp.1994—
+1K964637Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp.1996—
+1K970597Culture-Pak Collection and Transport System with Clinical Transport Media…Medical Packaging Corp.1997—
+1K972726Snap Swab Culture Collection and Transport SystemMedical Packaging Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199720
FIG. 1 — Lineage of K932337, 1994–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242976 Medical Wire Fecal Transwab Liquid Cary Blair…score 10.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

NumberDeviceApplicantDecidedDescendants
K964637Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp.19962
K970597Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair…Medical Packaging Corp.19971
K972726Snap Swab Culture Collection and Transport SystemMedical Packaging Corp.19970

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 devices

JSM Culture Media, Non-Propagating Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSM

3in 2025

2012: 12015: 42016: 22017: 12018: 12021: 12022: 52023: 32024: 92025: 3
2007high 9 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JSM

241in 2025

2015: 195 days median2022: 344 days median2023: 254 days median2024: 271 days median2025: 241 days median
2007high 344 (2022) · low 195 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JSM

1in 2022

2009: 32010: 12020: 42021: 12022: 1
2007high 4 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JSM

63in 2025

2009: 12011: 12012: 92013: 12014: 22015: 12016: 62017: 572018: 1312019: 812020: 472021: 422022: 362023: 482024: 212025: 63
2007high 131 (2018) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—31
20100—10
20110—01
20121—09
20130—01
20140—02
2015419501
20162—06
20171—057
20181—0131
20190—081
20200—447
20211—142
20225344136
20233254048
20249271021
20253241063
20260—0—
Cite this page

510(k) Report. “K932337: Culture-Pak 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/K932337

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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