510(k) · Cleared
ClearedGEM Premier ChemSTAT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JGS Electrode, Ion Specific, Sodium
Cleared on Feb 16, 2019 as substantially equivalent to K133407 (Instrumentation Laboratory CO, 2014) after a 58-day review. Its family tree reaches back 9 generations to 1980. 1 later device descends from it.
- Decided
- Feb 16, 2019
- Review
- 58 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K801848 (1980). 24 ancestors in all, the oldest K790608 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 5 generations between
- 3 generations backK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- 2 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 1 generation backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- This deviceK183549 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
- Descendant · cites it directly · 0 of its ownK223090 GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
Show all 9 generations
- Root · 9 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 8 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 7 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 6 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 5 generations backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- 4 generations backK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- 3 generations backK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- 2 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 1 generation backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- This deviceK183549 GEM Premier ChemSTATInstrumentation Laboratory CO · 2019
Most influential descendants
Showing 1 of 1 · See all- K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −8 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −7 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −6 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −5 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| −4 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| −3 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| −2 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| −1 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| 0 (this device) | K183549 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 | — |
| +1 | K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133407 | Gem Premier 4000Summary page 4…15, 2019 GEM Premier ChemSTAT Device Trade Name Predicate Device GEM Premier 4000 K133407 Regulatory Information Regulation… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223090 | GEM Premier ChemSTAT | 2023 | 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?
- The line of descent spans 39 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K223090 (Instrumentation Laboratory CO, 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K133407.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na+), Potassium (K+), Ionized Calcium (Ca++) and Chloride (Cl-) from arterial and venous heparinized whole blood. These parameters, along with derived…
Read the full statement (199 words)
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na+), Potassium (K+), Ionized Calcium (Ca++) and Chloride (Cl-) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s electrolyte balance.
Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
• Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
• Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
• Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183549: GEM Premier ChemSTAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183549
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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