510(k) Report

510(k) · Cleared

Cleared

IL Monarch 1000 Clinical Chemistry Analytical Sys.

K871973510(k) TraditionalCleared Jun 11, 198720-day reviewClass I21 CFR 862.2140

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

Instrumentation Laboratory CO · JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

Cleared on Jun 11, 1987 after a 20-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
Jun 11, 1987
Review
20 days
Class
Class I
Product code
JJG
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK871973 IL Monarch 1000 Clinical Chemistry Analytical Sys.Instrumentation Laboratory CO · 1987
  2. Descendant · cites it directly · 1 of its ownK972363 IL Test IronInstrumentation Laboratory CO · 1997
  3. Descendant · 2 generations on · 0 of its ownK051115 Sentinel Iron LiquidSentinel Ch. Srl · 2005
  4. Descendant · cites it directly · 0 of its ownK973306 IL Test Aptt-SPInstrumentation Laboratory CO · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K972363IL Test IronInstrumentation Laboratory CO · 1997 · cites it directly1descendant
  • K051115Sentinel Iron LiquidSentinel Ch. Srl · 2005 · 2 generations on0descendants
  • K973306IL Test Aptt-SPInstrumentation Laboratory CO · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871973IL Monarch 1000 Clinical Chemistry Analytical Sys.Instrumentation Laboratory CO1987—
+1K972363IL Test IronInstrumentation Laboratory CO1997—
+2K051115Sentinel Iron LiquidSentinel Ch. Srl2005—
+1K973306IL Test Aptt-SPInstrumentation Laboratory CO1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200510
FIG. 1 — Lineage of K871973, 1987–2005Source: 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.

Planning a device in JJG? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K972363IL Test IronInstrumentation Laboratory CO19971
K973306IL Test Aptt-SPInstrumentation Laboratory CO19970

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, K972363 (Instrumentation Laboratory CO, 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JJG devices

JJG Analyzer, Chemistry, Centrifugal, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJG

FDA has decided no JJG device since 2007.

Median 510(k) review, days · JJG

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

Recalls per year · JJG

No recall names JJG since 2007.

Adverse event reports per year · JJG

5in 2025

2008: 12009: 12012: 12015: 12018: 12020: 862021: 122022: 42023: 52024: 42025: 5
2007high 86 (2020) · low 0 (2007)2025

MAUDE reports naming product code JJG, 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—01
20090—01
20100—00
20110—00
20120—01
20130—00
20140—00
20150—01
20160—00
20170—00
20180—01
20190—00
20200—086
20210—012
20220—04
20230—05
20240—04
20250—05
20260—0—

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321 FDA decisions under this applicant name. See the company

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  • K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
  • K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO · 2022
  • K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 20222 recalls

Recent decisions in JJG

The JJG category page

  • K972409AG Chemistry Analyzer SystemLandmark Scientific, Inc. · 1997
  • K942782Piccolo (TM)Abaxis, Inc. · 19951 recall
  • K934592Epoc 2000 Point-of-Care Analyzer and Epoc 5-Chemistry Reagent RotorAbaxis, Inc. · 19941 recall
  • K920942Olympus AU800 Clinical Chemistry AnalyzerOlympus Corp. · 1992
  • K910222Cobas AlphaRoche Diagnostic Systems, Inc. · 1991

https://510kreport.com/device/K871973 · printed Nov 6, 2026

Cite this page

510(k) Report. “K871973: IL Monarch 1000 Clinical Chemistry Analytical Sys..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871973

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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