510(k) Report

510(k) · Cleared

Cleared

Cellognost Syphilis H

K896410510(k) TraditionalCleared May 15, 1990189-day reviewClass II21 CFR 866.3830

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

Behring Diagnostics, Inc. · GMT Antigens, Ha, Treponema Pallidum

Cleared on May 15, 1990 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 15, 1990
Review
189 days
Class
Class II
Product code
GMT
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K896410Source: FDA 510(k) database · 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 GMT? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All GMT devices

GMT Antigens, Ha, Treponema Pallidum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GMT

FDA has decided no GMT device since 2007.

Median 510(k) review, days · GMT

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

Recalls per year · GMT

No recall names GMT since 2007.

Adverse event reports per year · GMT

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code GMT, 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—00
20100—00
20110—00
20120—01
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 Behring Diagnostics, Inc.

146 FDA decisions under this applicant name. See the company

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  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
  • K973202Modification of Opus Ferritin Test SystemBehring Diagnostics, Inc. · 1997
  • K972316Opus D-DimerBehring Diagnostics, Inc. · 1997

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https://510kreport.com/device/K896410 · printed Nov 5, 2026

Cite this page

510(k) Report. “K896410: Cellognost Syphilis H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K896410

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