510(k) Report

510(k) · Cleared

Cleared

Multitrans Culture Collection and Transport System

K962843510(k) TraditionalCleared Sep 18, 199658-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

Starplex Scientific, Inc. · JSM Culture Media, Non-Propagating Transport

Cleared on Sep 18, 1996 after a 58-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Sep 18, 1996
Review
58 days
Class
Class I
Product code
JSM
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962843 Multitrans Culture Collection and Transport SystemStarplex Scientific, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK032246 Modification to Multitrans Culture Collection and Transport SystemStarplex Scientific, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K032246Modification to Multitrans Culture Collection and Transport SystemStarplex Scientific, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962843Multitrans Culture Collection and Transport SystemStarplex Scientific, Inc.1996—
+1K032246Modification to Multitrans Culture Collection and Transport SystemStarplex Scientific, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K962843, 1996–2003Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032246Modification to Multitrans Culture Collection and Transport SystemStarplex Scientific, Inc.20030

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, K032246 (Starplex Scientific, Inc., 2003) has gone furthest, with 0 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. “K962843: Multitrans Culture Collection and Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962843

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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