510(k) Report

510(k) · Cleared

Cleared

Sedratrol

K940430510(k) TraditionalCleared Feb 6, 1995371-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 Intl., Inc. · GJR Control, Red-Cell

Cleared on Feb 6, 1995 after a 371-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
Feb 6, 1995
Review
371 days
Class
Class II
Product code
GJR
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK940430 SedratrolMedical Specialties Intl., Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK972172 Esr Control-M Hematology Erythrocyte SedimentationR&D Systems, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK991876 Sedrite Plus Erythrocyte Sedimentation RateR&D Systems, Inc. · 1999
  4. Descendant · cites it directly · 0 of its ownK972170 Esr Control-HC Hematology Erythrocyte SedimentationR&D Systems, Inc. · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K972172Esr Control-M Hematology Erythrocyte SedimentationR&D Systems, Inc. · 1997 · cites it directly1descendant
  • K991876Sedrite Plus Erythrocyte Sedimentation RateR&D Systems, Inc. · 1999 · 2 generations on0descendants
  • K972170Esr Control-HC Hematology Erythrocyte SedimentationR&D Systems, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940430SedratrolMedical Specialties Intl., Inc.1995—
+1K972172Esr Control-M Hematology Erythrocyte SedimentationR&D Systems, Inc.1997—
+2K991876Sedrite Plus Erythrocyte Sedimentation RateR&D Systems, Inc.1999—
+1K972170Esr Control-HC Hematology Erythrocyte SedimentationR&D Systems, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199910
FIG. 1 — Lineage of K940430, 1995–1999Source: 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.

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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K972172Esr Control-M Hematology Erythrocyte SedimentationR&D Systems, Inc.19971
K972170Esr Control-HC Hematology Erythrocyte SedimentationR&D Systems, Inc.19970

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, K972172 (R&D Systems, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GJR devices

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

FDA decisions per year · GJR

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GJR

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

Recalls per year · GJR

No recall names GJR since 2007.

Adverse event reports per year · GJR

No MAUDE report names GJR since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—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—00
20240—00
20250—00
20260—0—

More from Medical Specialties Intl., Inc.

5 FDA decisions under this applicant name. See the company

  • K972655Control SyringeMedical Specialties Intl., Inc. · 1997
  • K972654ManifoldMedical Specialties Intl., Inc. · 1997
  • K952385Hema-Trol Q-CheckMedical Specialties Intl., Inc. · 1995
  • K895373Hematology ControlMedical Specialties Intl., Inc. · 1989

Recent decisions in GJR

The GJR category page

  • K080016NRBC-Chex for AdviaStreck · 2008
  • K060083NRBC-Chex for LHStreck · 2006
  • K000076Cell-ChexStreck Laboratories, Inc. · 2000
  • K900484Ret-CheckStreck Laboratories, Inc. · 1990

https://510kreport.com/device/K940430 · printed Nov 5, 2026

Cite this page

510(k) Report. “K940430: Sedratrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K940430

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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