510(k) Report

510(k) · Cleared

Cleared

Sas Francisella Tularensis Antigen

K952138510(k) TraditionalCleared Jul 17, 199570-day reviewClass II21 CFR 866.3280

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sa Scientific, Inc. · GSL Antigens, Slide And Tube, Francisella Tularensis

Cleared on Jul 17, 1995 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 17, 1995
Review
70 days
Class
Class II
Product code
GSL
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2013: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952138 Sas Francisella Tularensis AntigenSa Scientific, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK072547 Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc. · 2007
  3. Descendant · 2 generations on · 0 of its ownK131936 Jbaids Tularemia Detection KitBiofire Diagnostics, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc. · 2007 · cites it directly1descendant
  • K131936Jbaids Tularemia Detection KitBiofire Diagnostics, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952138Sas Francisella Tularensis AntigenSa Scientific, Inc.1995—
+1K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc.2007—
+2K131936Jbaids Tularemia Detection KitBiofire Diagnostics, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201310
FIG. 1 — Lineage of K952138, 1995–2013Source: 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 GSL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K072547Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Idaho Technology, Inc.20071

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, K072547 (Idaho Technology, Inc., 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GSL devices

GSL Antigens, Slide And Tube, Francisella Tularensis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GSL

FDA has decided no GSL device since 2007.

Median 510(k) review, days · GSL

Too few GSL 510(k)s in any year since 2007 to give a median.

Recalls per year · GSL

No recall names GSL since 2007.

Adverse event reports per year · GSL

No MAUDE report names GSL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Sa Scientific, Inc.

199 FDA decisions under this applicant name. See the company

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  • K080380Sas Influenza a & B TestSa Scientific, Inc. · 2009
  • K041439Sas Influenza B TestSa Scientific, Inc. · 2004
  • K041441Sas Influenza a TestSa Scientific, Inc. · 2004
  • K030628Sas RSV Control KitSa Scientific, Inc. · 2003

https://510kreport.com/device/K952138 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952138: Sas Francisella Tularensis Antigen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952138

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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