510(k) Report

510(k) · Cleared

Cleared

Cryo Check Lupus Plasma

K952623510(k) TraditionalCleared Nov 6, 1995151-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

Precision Biologicals, Inc. · GGC Control, Plasma, Abnormal

Cleared on Nov 6, 1995 after a 151-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Nov 6, 1995
Review
151 days
Class
Class II
Product code
GGC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2003: 1 descendant cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952623 Cryo Check Lupus PlasmaPrecision Biologicals, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK061803 Sta - Control LA 1+2Diagnostica Stago, Inc. · 2006
  3. Descendant · 2 generations on · 0 of its ownK142132 Pool NormDiagnostics Stago S.A.S. · 2014
  4. Descendant · cites it directly · 0 of its ownK032804 Cryocheck Weak Lupus Positive ControlPrecision Biologic · 2003

Most influential descendants

Showing 3 of 3 · See all
  • K061803Sta - Control LA 1+2Diagnostica Stago, Inc. · 2006 · cites it directly1descendant
  • K142132Pool NormDiagnostics Stago S.A.S. · 2014 · 2 generations on0descendants
  • K032804Cryocheck Weak Lupus Positive ControlPrecision Biologic · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952623Cryo Check Lupus PlasmaPrecision Biologicals, Inc.1995—
+1K061803Sta - Control LA 1+2Diagnostica Stago, Inc.2006—
+2K142132Pool NormDiagnostics Stago S.A.S.2014—
+1K032804Cryocheck Weak Lupus Positive ControlPrecision Biologic2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
201410
FIG. 1 — Lineage of K952623, 1995–2014Source: 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
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? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061803Sta - Control LA 1+2Diagnostica Stago, Inc.20061
K032804Cryocheck Weak Lupus Positive ControlPrecision Biologic20030

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, K061803 (Diagnostica Stago, Inc., 2006) 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 Precision Biologicals, Inc.

20 FDA decisions under this applicant name. See the company

  • K981173Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML)Precision Biologicals, Inc. · 1999
  • K981174Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (1.5ML)Precision Biologicals, Inc. · 1999
  • K982062Cryo-Check PNP Platelet Lysate, Model PNP-10Precision Biologicals, Inc. · 1999
  • K971219Cryo Check Inr Validation SetPrecision Biologicals, Inc. · 1997
  • K971222Cryo Check Apc Resistant PlasmaPrecision Biologicals, 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/K952623 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952623: Cryo Check Lupus Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952623

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