510(k) Report

510(k) · Cleared

Cleared

Coulter Positive Control Cells

K894651510(k) TraditionalCleared Sep 13, 198951-day reviewClass II21 CFR 864.8625

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

Coulter Corp. · GGL Control, White-Cell

Cleared on Sep 13, 1989 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Sep 13, 1989
Review
51 days
Class
Class II
Product code
GGL
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2015: 1 descendant cleared2001: 1 descendant cleared1990200020102020
  1. This deviceK894651 Coulter Positive Control CellsCoulter Corp. · 1989
  2. Descendant · cites it directly · 2 of its ownK984216 Immuno-Trol Control CellsCoulter Corp. · 1999
  3. Descendant · 2 generations on · 1 of its ownK013842 Immuno-Trol Low CellsBeckman Coulter, Inc. · 2001
  4. Descendant · 2 generations on · 0 of its ownK141932 Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel…Beckman Coulter, Inc. · 2015 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K984216Immuno-Trol Control CellsCoulter Corp. · 1999 · cites it directly2descendants
  • K013842Immuno-Trol Low CellsBeckman Coulter, Inc. · 2001 · 2 generations on1descendant
  • K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K894651Coulter Positive Control CellsCoulter Corp.1989—
+1K984216Immuno-Trol Control CellsCoulter Corp.1999—
+2K013842Immuno-Trol Low CellsBeckman Coulter, Inc.2001—
+2K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios…Beckman Coulter, Inc.20156

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
201510
FIG. 1 — Lineage of K894651, 1989–2015Source: 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 GGL? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K984216Immuno-Trol Control CellsCoulter Corp.19992

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, K984216 (Coulter Corp., 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GGL devices

GGL Control, White-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGL

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGL

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

Recalls per year · GGL

No recall names GGL since 2007.

Adverse event reports per year · GGL

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code GGL, 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
20091—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—01
20240—00
20250—00
20260—0—

More from Coulter Corp.

51 FDA decisions under this applicant name. See the company

  • K993356Coulter Hematology Analyzers with Irf & MRV AnalysesCoulter Corp. · 2000
  • K991070Coulter Z2 AnalyzerCoulter Corp. · 1999
  • K990327Reticone System for Epics XL Flow Cytometry SystemsCoulter Corp. · 1999
  • K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 19991 Class I recall
  • K990352Coulter AC T Diff 2 AnalyzerCoulter Corp. · 19991 recall

Recent decisions in GGL

The GGL category page

  • K083926CD4 CountStreck · 2009
  • K051633CD-Chex Plus BCStreck · 2005
  • K993126CD-Chex CD 34Streck Laboratories, Inc. · 1999
  • K960894CD-Chex + RBCStreck Laboratories, Inc. · 1996
  • K931825CD-Chex CD4 LowStreck Laboratories, Inc. · 1994

https://510kreport.com/device/K894651 · printed Nov 4, 2026

Cite this page

510(k) Report. “K894651: Coulter Positive Control Cells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894651

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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