510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Olympus Magnesium Reagent

K944407510(k) TraditionalCleared Dec 27, 1994110-day reviewClass I21 CFR 862.1495Recalls 1

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

Olympus America, Inc. · JGJ Photometric Method, Magnesium

Cleared on Dec 27, 1994 after a 110-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Dec 27, 1994
Review
110 days
Class
Class I
Product code
JGJ
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared1990200020102020
  1. This deviceK944407 Olympus Magnesium ReagentOlympus America, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK111915 Magnesium AssaySekisui Diagnostics P.E.I., Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K111915Magnesium AssaySekisui Diagnostics P.E.I., Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944407Olympus Magnesium ReagentOlympus America, Inc.1994—
+1K111915Magnesium AssaySekisui Diagnostics P.E.I., Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K944407, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · 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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  • 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K111915Magnesium AssaySekisui Diagnostics P.E.I., Inc.20110

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 8, 2021Class IIZ-0692-2022Under Investigation by firmLipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K111915 (Sekisui Diagnostics P.E.I., Inc., 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JGJ devices

JGJ Photometric Method, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGJ

2in 2018

2007: 12009: 22011: 12012: 12017: 22018: 2
2007high 2 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JGJ

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

Recalls per year · JGJ

1in 2024

2012: 12013: 12015: 12016: 12019: 12020: 22021: 12022: 12024: 1
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JGJ

22in 2025

2008: 12009: 42010: 42011: 132012: 222013: 262014: 42015: 242016: 42017: 182018: 212019: 312020: 342021: 332022: 422023: 312024: 172025: 22
2007high 42 (2022) · low 0 (2007)2025

MAUDE reports naming product code JGJ, 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
20071—00
20080—01
20092—04
20100—04
20111—013
20121—122
20130—126
20140—04
20150—124
20160—14
20172—018
20182—021
20190—131
20200—234
20210—133
20220—142
20230—031
20240—117
20250—022
20260—0—

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

Recent decisions in JGJ

The JGJ category page

  • K181748MagnesiumAbbott Laboratories · 2018
  • K173294MagnesiumAbbott Laboratories · 2018
  • K162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd. · 20171 recall
  • K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc. · 2017
  • K122302Ace Magnesium RegentAlfa Wassermann Diagnostics Technologies, LLC · 2012

https://510kreport.com/device/K944407 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944407: Olympus Magnesium Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944407

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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