510(k) Report

510(k) · Cleared

Cleared

CD8 Cytospheres Kit

K923951510(k) TraditionalCleared Apr 25, 1994627-day reviewClass II21 CFR 864.5220

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

Coulter Electronics, Inc. · MAM Dna-Probe, B And T Lymphocyte

Cleared on Apr 25, 1994 after a 627-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 25, 1994
Review
627 days
Class
Class II
Product code
MAM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K923951Source: 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.

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  • 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 MAM devices

MAM Dna-Probe, B And T Lymphocyte: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAM

FDA has decided no MAM device since 2007.

Median 510(k) review, days · MAM

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

Recalls per year · MAM

No recall names MAM since 2007.

Adverse event reports per year · MAM

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2025

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

More from Coulter Electronics, Inc.

101 FDA decisions under this applicant name. See the company

  • K930119Coulter Retic-C Cell ControlCoulter Electronics, Inc. · 1993
  • K921279CD4 Cytospheres KitCoulter Electronics, Inc. · 1992
  • K923530Coulter Multi-Q-PrepCoulter Electronics, Inc. · 1992
  • K922181Coulter MH009Coulter Electronics, Inc. · 1992
  • K922704Coulter Maxm W/ AutoloaderCoulter Electronics, Inc. · 19921 recall

Recent decisions in MAM

The MAM category page

  • P880016/S004Oncor B/T Gene Rearrangement TestOncor, Inc. · 1993
  • P880016/S003Oncor B/T Gene Rearrangement TestOncor, Inc. · 1992
  • P880016/S002Oncor B/T Gene Rearrangement TestOncor, Inc. · 1990
  • P880016/S001Oncor B/T Gene Rearrangement TestOncor, Inc. · 1990
  • P880016Oncor B/T Gene Rearrangement TestOncor, Inc. · 1989

https://510kreport.com/device/K923951 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923951: CD8 Cytospheres Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923951

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