510(k) · Cleared
Recalled · Class II · 2026GEM Premier 5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Aug 20, 2021 as substantially equivalent to K173403 (Instrumentation Laboratory CO, 2017) and 3 other predicates after a 235-day review. Its family tree reaches back 10 generations to 1980. 1 later device descends from it. It has been recalled 25 times.
- Decided
- Aug 20, 2021
- Review
- 235 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 25
- Predicates
- 4
Its longest line of descent runs back 10 generations to K801848 (1980). 40 ancestors in all, the oldest K790608 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 6 generations between
- 3 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 2 generations backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- 1 generation backK160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin…Instrumentation Laboratory CO · 2016
- This deviceK203790 GEM Premier 5000Instrumentation Laboratory CO · 2021
- Descendant · cites it directly · 0 of its ownK223608 GEM Premier 7000 with IQM3Instrumentation Laboratory Company · 2023 · Recalled
Show all 10 generations
- Root · 10 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 9 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 8 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 7 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 6 generations backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- 5 generations backK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- 4 generations backK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- 3 generations backK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- 2 generations backK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- 1 generation backK160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin…Instrumentation Laboratory CO · 2016
- This deviceK203790 GEM Premier 5000Instrumentation Laboratory CO · 2021
Most influential descendants
Showing 1 of 1 · See all- K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −9 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −8 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −7 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −6 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| −5 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| −4 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| −3 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| −2 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| −1 | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin… | Instrumentation Laboratory CO | 2016 | — |
| 0 (this device) | K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021 | — |
| +1 | K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K173403 | GEM Premier 5000Summary page 5…August 18, 2021 Device Trade Name GEM Premier 5000 K173403,K160415, Predicate Devices GEM Premier 5000 K160402, K160225… | 2017 |
| * | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Summary page 5…August 18, 2021 Device Trade Name GEM Premier 5000 K173403,K160415, Predicate Devices GEM Premier 5000 K160402, K160225… | 2016 |
| * | K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Summary page 5…K173403,K160415, Predicate Devices GEM Premier 5000 K160402, K160225 Regulatory Information GEM Premi… | 2016 |
| * | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Summary page 5…K173403,K160415, Predicate Devices GEM Premier 5000 K160402, K160225 Regulatory Information GEM Premier 5000… | 2016 |
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 |
|---|---|---|---|
| K223608 | GEM Premier 7000 with IQM3 | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2900-2026 | Nonconforming Material/Component | The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and… |
| May 8, 2026 | Class II | Z-2821-2026 | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price… |
| May 8, 2026 | Class II | Z-2824-2026 | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price… |
| May 8, 2026 | Class II | Z-2823-2026 | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price… |
| May 8, 2026 | Class II | Z-2825-2026 | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price… |
| May 8, 2026 | Class II | Z-2826-2026 | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price… |
| Jan 20, 2026 | Class II | Z-1541-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1526-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1542-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1530-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1525-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1533-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1536-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1524-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1531-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1538-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1540-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1529-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1539-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1534-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1532-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1528-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1527-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1537-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
| Jan 20, 2026 | Class II | Z-1543-2026 | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences… |
The 5 latest of 25 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 16 of the 40 ancestors have a recall of any class.
- Of its descendants, K223608 (Instrumentation Laboratory Company, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | 1 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze 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 pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2*) parameters…
Read the full statement (522 words)
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze
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 pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose,
lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2*) parameters from arterial,
venous or capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a
patient’s acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.
*s02 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.
* pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base
disturbances.
* 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.
* lonized 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.
» 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).
* Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances
including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and 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;
» in the diagnosis of hyperlactatemia.
» Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
» CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by
measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.
» Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood
for the detection of anemia.
» COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an
aid in the diagnosis of carbon monoxide poisoning.
» MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
» HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure
oxygen status.
* O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure
oxygen status.
* sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin
plus deoxyhemoglobin, is used to measure oxygen status.
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/K203790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203790: GEM Premier 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203790
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