510(k) · Cleared
ClearedGEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GKF Instrument, Hematocrit, Automated
Cleared on Dec 14, 2016 as substantially equivalent to K133407 (Instrumentation Laboratory CO, 2014) after a 306-day review. Its family tree reaches back 9 generations to 1980. 2 later devices descend from it.
- Decided
- Dec 14, 2016
- Review
- 306 days
- Class
- Class II
- Product code
- GKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K801848 (1980). 24 ancestors in all, the oldest K790608 (1979). 2 later devices descend 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 deviceK160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin…Instrumentation Laboratory CO · 2016
- Descendant · cites it directly · 1 of its ownK203790 GEM Premier 5000Instrumentation Laboratory CO · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK223608 GEM Premier 7000 with IQM3Instrumentation Laboratory Company · 2023 · Recalled
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 deviceK160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin…Instrumentation Laboratory CO · 2016
Most influential descendants
Showing 2 of 2 · See allView 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) | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin… | Instrumentation Laboratory CO | 2016 | — |
| +1 | K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021 | 25 |
| +2 | 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 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 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 GKF? 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
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 5…bin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) Predicate Device GEM Premier 4000 K133407 Regulatory Information GEM Premier 5000… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203790 | GEM Premier 5000 | 2021 | 1 |
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 36 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K203790 (Instrumentation Laboratory CO, 2021) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K133407.
How does its category compare?
All GKF devicesGKF Instrument, Hematocrit, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GKF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKF
Too few GKF 510(k)s in any year since 2007 to give a median.
Recalls per year · GKF
No recall names GKF since 2007.
Adverse event reports per year · GKF
2in 2017
MAUDE reports naming product code GKF, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
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 Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb, COHb, MetHb, HHb, sO2 from venous, arterial…
Read the full statement (248 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 Hematocrit and Total Hemoglobin from venous and arterial heparinized
whole blood, as well as quantitative measurements of O2Hb, COHb, MetHb, HHb, sO2 from venous, arterial and
capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s
oxygen delivery capacity.
• 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).
• 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
oxygenation status.
• O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure
oxygenation status.
• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin
plus deoxyhemoglobin, is used to measure oxygenation status.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160415: GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160415
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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