510(k) · Cleared

Cleared

Synermed IR 200 Chemistry Analyzer

K971491510(k) TraditionalCleared Jun 26, 199763-day reviewClass I21 CFR 862.2170

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

Synermed, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on Jun 26, 1997 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Jun 26, 1997
Review: 63 days
Class: Class I
Product code: JJF
Recalls: None
Predicates: 0

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

This deviceK971491 Synermed IR 200 Chemistry AnalyzerSynermed, Inc. · 1997
Descendant · cites it directly · 1 of its ownK013654 Precision Systems Analette Chemistry AnalyzerPrecision Systems, Inc. · 2002
Descendant · cites it directly · 0 of its ownK024182 Precision Systems Analette Chemistry Analyzer Stanbio Laboratory…Precision Systems, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K013654Precision Systems Analette Chemistry AnalyzerPrecision Systems, Inc. · 2002 · cites it directly1descendant
K024182Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsPrecision Systems, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971491	Synermed IR 200 Chemistry Analyzer	Synermed, Inc.	1997	—
+1	K013654	Precision Systems Analette Chemistry Analyzer	Precision Systems, Inc.	2002	—
+1	K024182	Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents	Precision Systems, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0

FIG. 1 — Lineage of K971491, 1997–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJF? 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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K013654	Precision Systems Analette Chemistry Analyzer	Precision Systems, Inc.	2002	1
K024182	Precision Systems Analette Chemistry Analyzer Stanbio Laboratory Reagents	Precision Systems, Inc.	2003	0

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, K013654 (Precision Systems, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JJF devices

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

FDA decisions per year · JJF

FDA has decided no JJF device since 2007.

Median 510(k) review, days · JJF

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

Recalls per year · JJF

2in 2018

2007high 3 (2012) · low 0 (2008)2026

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

Adverse event reports per year · JJF

2in 2025

2007high 21 (2010) · low 0 (2015)2025

MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	10
2008	—	0	2
2009	—	0	3
2010	—	0	21
2011	—	0	19
2012	—	3	8
2013	—	0	1
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	2	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument that sequentially quantitates levels of constituents in serum, plasma or urine. Testing is selective, i.e, only selected tests or profiles or automatic repeats of selected tests are performed on each sample.

The Synermed IR200 analyzer is specifically designed to perform tests with Synermed reagents or reagent applications recommended by Synermed. Consequently, no representation as to the general utility of the Synermed IR200 with other than Synermed reagents or approved applications is made and none should be inferred.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971491 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971491: Synermed IR 200 Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971491

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026