510(k) Report

510(k) · Cleared

Cleared

Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis

K051794510(k) TraditionalCleared Aug 16, 200546-day reviewClass II21 CFR 866.3045

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

Office of the Surgeon General, U.S. Army · NVQ Bacteriophage And Controls, B. Anthracis Lysis

Cleared on Aug 16, 2005 after a 46-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
Aug 16, 2005
Review
46 days
Class
Class II
Product code
NVQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2015: 1 descendant cleared20052010201520202025
  1. This deviceK051794 Gamma Phage Lysis Assay for the Identification of Bacillus AnthracisOffice of the Surgeon General, U.S. Army · 2005
  2. Descendant · cites it directly · 0 of its ownK143592 Gamma Phage Lysis Assay for the Identification of Bacillus AnthracThe Surgeon General, Department of the Army · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K143592Gamma Phage Lysis Assay for the Identification of Bacillus AnthracThe Surgeon General, Department of the Army · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051794Gamma Phage Lysis Assay for the Identification of Bacillus AnthracisOffice of the Surgeon General, U.S. Army2005—
+1K143592Gamma Phage Lysis Assay for the Identification of Bacillus AnthracThe Surgeon General, Department of the Army2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K051794, 2005–2015Source: 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.

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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K143592Gamma Phage Lysis Assay for the Identification of Bacillus AnthracThe Surgeon General, Department of the Army20150

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, K143592 (The Surgeon General, Department of the Army, 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NVQ devices

NVQ Bacteriophage And Controls, B. Anthracis Lysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NVQ

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVQ

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

Recalls per year · NVQ

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · NVQ

No MAUDE report names NVQ 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
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—10
20230—00
20240—00
20250—00
20260—0—

Recent decisions in NVQ

The NVQ category page

  • K143592Gamma Phage Lysis Assay for the Identification of Bacillus AnthracThe Surgeon General, Department of the Army · 2015

https://510kreport.com/device/K051794 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051794: Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051794

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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