510(k) Report

510(k) · Cleared

Cleared

Msi-HCT

K924926510(k) TraditionalCleared Jan 7, 199399-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

Medical Specialties, Inc. · GLK Control, Hematocrit

Cleared on Jan 7, 1993 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 7, 1993
Review
99 days
Class
Class II
Product code
GLK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K924926Source: 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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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 GLK devices

GLK Control, Hematocrit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GLK

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GLK

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

Recalls per year · GLK

No recall names GLK since 2007.

Adverse event reports per year · GLK

1in 2020

2007: 22020: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code GLK, 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—02
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Medical Specialties, Inc.

40 FDA decisions under this applicant name. See the company

  • K946201Stand, InfusionMedical Specialties, Inc. · 1995
  • K931947CheckpointMedical Specialties, Inc. · 1993
  • K926095Refractrol-SPMedical Specialties, Inc. · 1993
  • K896566Modified Fox Extra Gram Negative and PositiveMedical Specialties, Inc. · 1990
  • K883851Msi-Cal 8Medical Specialties, Inc. · 1988

Recent decisions in GLK

The GLK category page

  • K121467Eurotrol Hematocrit ControlEurotrol B.V. · 2013
  • K021924Medica Easyqc Hematocrit ControlBionostics, Inc. · 2002
  • K020618Aalto Scientific Mirco Hematocrit ControlAalto Scientific, Ltd. · 2002
  • K964452HematachekRichmond Diagnostics, Inc. · 1997
  • K961807Certain HCT Level a & Level B/CVM HCT Levels 1,2,3, & 4Ciba Corning Diagnostics Corp. · 1996

https://510kreport.com/device/K924926 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924926: Msi-HCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924926

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