510(k) Report

510(k) · Cleared

Cleared

Sas Francisella Tularensis Antiserum

K952141510(k) TraditionalCleared Jul 21, 199574-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. · GSK Antiserum, Francisella Tularensis

Cleared on Jul 21, 1995 after a 74-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 21, 1995
Review
74 days
Class
Class II
Product code
GSK
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 deviceK952141 Sas Francisella Tularensis AntiserumSa 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)K952141Sas Francisella Tularensis AntiserumSa 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 K952141, 1995–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 GSK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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 GSK devices

GSK Antiserum, Francisella Tularensis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GSK

FDA has decided no GSK device since 2007.

Median 510(k) review, days · GSK

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

Recalls per year · GSK

No recall names GSK since 2007.

Adverse event reports per year · GSK

No MAUDE report names GSK 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

  • K100227Sas Flualert a&B, Sas Influenza a TestSa Scientific, Inc. · 2010
  • 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/K952141 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952141: Sas Francisella Tularensis Antiserum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952141

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026