510(k) Report

510(k) · Cleared

Cleared

S-Cal Hematology Calibrator

K862122510(k) TraditionalCleared May 20, 1987351-day reviewClass II21 CFR 864.8175

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

Coulter Electronics, Inc. · KRY Calibrator For Platelet Counting

Cleared on May 20, 1987 after a 351-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 20, 1987
Review
351 days
Class
Class II
Product code
KRY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K862122Source: 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 KRY? 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 KRY devices

KRY Calibrator For Platelet Counting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRY

FDA has decided no KRY device since 2007.

Median 510(k) review, days · KRY

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

Recalls per year · KRY

No recall names KRY since 2007.

Adverse event reports per year · KRY

1in 2012

2011: 52012: 1
2007high 5 (2011) · low 0 (2007)2025

MAUDE reports naming product code KRY, 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—05
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 Coulter Electronics, Inc.

101 FDA decisions under this applicant name. See the company

  • K923951CD8 Cytospheres KitCoulter Electronics, Inc. · 1994
  • 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

Recent decisions in KRY

The KRY category page

  • K852016Laser Plateletcal/MultipleR&D Systems, Inc. · 1985
  • K843910Coulter Mean Platelet Volume CalibratorCoulter Electronics, Inc. · 1985
  • K840794S-Cal Hematology CalibratorCoulter Electronics, Inc. · 1984
  • K821851Control Diagnostics Platelet ControlImmunogenetics · 1982
  • K781601Tekni-CalStreck Laboratories, Inc. · 1978

https://510kreport.com/device/K862122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862122: S-Cal Hematology Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862122

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