510(k) Report

510(k) · Cleared

Cleared

Snap Swab Culture Collection and Transport System

K972726510(k) TraditionalCleared Oct 8, 199779-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 Oct 8, 1997 as substantially equivalent to K932337 (Medical Packaging Corp., 1994) and 3 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1988.

Decided
Oct 8, 1997
Review
79 days
Class
Class I
Product code
JSM
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K881105 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestorsK881105 · Culture Collection Device · Medical Packaging Corp. · 1988K964637 · Culture Collection and Transport System, Modified Amies Media · Medical Packaging Corp. · 1996K970597 · Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option) · Medical Packaging Corp. · 19971986198819901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K970597 · Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option) · Medical Packaging Corp. · 1997K964637 · Culture Collection and Transport System, Modified Amies Media · Medical Packaging Corp. · 1996K881105 · Culture Collection Device · Medical Packaging Corp. · 19880
  1. Root · 3 generations backK881105 Culture Collection DeviceMedical Packaging Corp. · 1988
  2. 2 generations backK964637 Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp. · 1996
  3. 1 generation backK970597 Culture-Pak Collection and Transport System with Clinical Transport…Medical Packaging Corp. · 1997
  4. This deviceK972726 Snap Swab Culture Collection and Transport SystemMedical Packaging Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K881105Culture Collection DeviceMedical Packaging Corp.1988—
−2K964637Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp.1996—
−1K970597Culture-Pak Collection and Transport System with Clinical Transport Media…Medical Packaging Corp.1997—
0 (this device)K972726Snap Swab Culture Collection and Transport SystemMedical Packaging Corp.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
FIG. 1 — Lineage of K972726, 1988–1997Source: 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), 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. #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
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K932337Culture-Pak Collection and Transport System
Summary page 1
…MMON NAME: Microbiological specimen Culture Collection and Transport device PREDICATE DEVICE(S): CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K932337/S1 and K936078 ), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637, CULTURE-PAK™ Collect…
Medical Packaging Corp.1994—
*K936078Culture-Pak Collection/Transport System, Modified
Summary page 1
…obiological specimen Culture Collection and Transport device PREDICATE DEVICE(S): CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K932337/S1 and K936078 ), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637, CULTURE-PAK™ Collection and Transpo…
Medical Packaging Corp.1994—
*K964637Culture Collection and Transport System, Modified Amies Media
Summary page 1
…AK™ Collection and Transport System, Modified Stuart's Media (K932337/S1 and K936078 ), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637, CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, K970597, Medical Packaging Corporation, Camarillo, CA.…
Medical Packaging Corp.1996—
*K970597Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair…
Summary page 1
…078 ), and CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, K964637, CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, K970597, Medical Packaging Corporation, Camarillo, CA. Intended Use Medical Packaging Corporation's SNAP SWAB™ Culture Collection and T…
Medical Packaging Corp.1997—

Also cleared against K932337: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 7 months on median.
  • None of the 5 ancestors has a recall.
  • 2 other devices also cite its predicate K932337.

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—

What is it indicated for?

Medical Packaging Corporation's SNAP SWAB™ Culture Collection and Transport System is intended to be used for the collection, preservation, and transport of bactenological specimens to the laboratory for evaluation. The media is intended to preserve the intcg;rity of the specimen as well as minimize overgrowth of other organisms during transport.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K932337

2 other devices cite the same predicate.

  • K970597Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option)Medical Packaging Corp. · 1997
  • K964637Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp. · 1996

More from Medical Packaging Corp.

10 FDA decisions under this applicant name. See the company

  • K003761Nat - Nucleic Acid TransportMedical Packaging Corp. · 2001
  • K970597Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option)Medical Packaging Corp. · 1997
  • K964637Culture Collection and Transport System, Modified Amies MediaMedical Packaging Corp. · 1996
  • K932337Culture-Pak Collection and Transport SystemMedical Packaging Corp. · 1994
  • K936078Culture-Pak Collection/Transport System, ModifiedMedical Packaging Corp. · 1994

Recent decisions in JSM

The JSM category page

  • K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd. · 2025
  • K250205Babio® Virus Transport Kit (Non-inactivating)Jinan Babio Biotechnology Co., Ltd. · 2025
  • K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd. · 2025
  • K232565UriSponge™Copan Italia Spa · 2024
  • K220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc. · 2024

https://510kreport.com/device/K972726 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972726: Snap Swab Culture 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/K972726

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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