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 · CGA Glucose Oxidase, Glucose
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
- CGA
- 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 deviceK183546 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 deviceK183546 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) | K183546 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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…1, 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 CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 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 Glucose (Glu), Lactate (Lac), Hematocrit (Hct), pH and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These…
Read the full statement (203 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 Glucose (Glu), Lactate (Lac), Hematocrit (Hct), pH and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s acid/base status and metabolite balance.
• Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
• Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
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/K183546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183546: 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/K183546
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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