510(k) Report

510(k) · Cleared

Cleared

Control Plasma P

K924405510(k) TraditionalCleared Dec 1, 199292-day reviewClass II21 CFR 864.5425

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

Behring Diagnostics, Inc. · GGC Control, Plasma, Abnormal

Cleared on Dec 1, 1992 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Dec 1, 1992
Review
92 days
Class
Class II
Product code
GGC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK924405 Control Plasma PBehring Diagnostics, Inc. · 1992
  2. Descendant · cites it directly · 1 of its ownK023312 Control Plasma PDade Behring, Inc. · 2002
  3. Descendant · 2 generations on · 0 of its ownK042209 Control Plasma N and Control Plasma PDade Behring, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all
  • K023312Control Plasma PDade Behring, Inc. · 2002 · cites it directly1descendant
  • K042209Control Plasma N and Control Plasma PDade Behring, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924405Control Plasma PBehring Diagnostics, Inc.1992—
+1K023312Control Plasma PDade Behring, Inc.2002—
+2K042209Control Plasma N and Control Plasma PDade Behring, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
FIG. 1 — Lineage of K924405, 1992–2004Source: 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 GGC? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K023312Control Plasma PDade Behring, Inc.20021

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, K023312 (Dade Behring, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GGC devices

GGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGC

1in 2011

2007: 12010: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGC

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

Recalls per year · GGC

No recall names GGC since 2007.

Adverse event reports per year · GGC

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code GGC, 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
20071—00
20080—00
20090—00
20101—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
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

  • K973832Opus HLH ControlsBehring Diagnostics, Inc. · 1997
  • 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

Recent decisions in GGC

The GGC category page

  • K102552Hemosil LA Positive ControlInstrumentation Laboratory CO · 2011
  • K100103Specialty Assayed Control-2Helena Laboratories · 2010
  • K062306Plasmacon N, Plasmacon L-1, Plasmacon L-2R2 Diagnostics, Inc. · 2007
  • K061803Sta - Control LA 1+2Diagnostica Stago, Inc. · 2006
  • K032804Cryocheck Weak Lupus Positive ControlPrecision Biologic · 2003

https://510kreport.com/device/K924405 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924405: Control Plasma P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924405

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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