510(k) · Cleared
ClearedGem Premier 4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · CEM Electrode, Ion Specific, Potassium
Cleared on May 3, 2012 as substantially equivalent to K061974 (Instrumentation Laboratory CO, 2006) and 1 other predicate after a 209-day review. Its family tree reaches back 7 generations to 1980. 11 later devices descend from it.
- Decided
- May 3, 2012
- Review
- 209 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K801848 (1980). 22 ancestors in all, the oldest K790608 (1979). 11 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 6 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 5 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 4 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 3 generations backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- 2 generations backK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- 1 generation backK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- This deviceK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- Descendant · cites it directly · 10 of its ownK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- Descendant · 2 generations on · 2 of its ownK173403 GEM Premier 5000Instrumentation Laboratory CO · 2017
- Descendant · cites it directly · 2 of its ownK160225 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride…Instrumentation Laboratory CO · 2016
- Descendant · 2 generations on · 2 of its ownK160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin…Instrumentation Laboratory CO · 2016
- Descendant · 2 generations on · 2 of its ownK160402 GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total…Instrumentation Laboratory CO · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K133407Gem Premier 4000Instrumentation Laboratory CO · 2014 · cites it directly10descendants
- K173403GEM Premier 5000Instrumentation Laboratory CO · 2017 · 2 generations on2descendants
- K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO · 2016 · cites it directly2descendants
- K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Instrumentation Laboratory CO · 2016 · 2 generations on2descendants
- K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −6 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −5 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −4 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −3 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| −2 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| −1 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| 0 (this device) | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| +1 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| +2 | K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017 | — |
| +1 | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized… | Instrumentation Laboratory CO | 2016 | — |
| +2 | K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin… | Instrumentation Laboratory CO | 2016 | — |
| +2 | K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | Instrumentation Laboratory CO | 2016 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4…Summary page 2…uct Code Hematocrit Control j 864.8625 Class 11 GLK Predicate Device: GEM Premier 4000 with iQM Original K061974; Update K093623 Description of Device Modification: The potassium (K+) sensor membrane on the GEM Premier 4000 is being modif… | 2006 |
| * | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Summary page 2…atocrit Control j 864.8625 Class 11 GLK Predicate Device: GEM Premier 4000 with iQM Original K061974; Update K093623 Description of Device Modification: The potassium (K+) sensor membrane on the GEM Premier 4000 is being modified to lower the… | 2010 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 9 of the 22 ancestors have a recall of any class.
- Of its descendants, K133407 (Instrumentation Laboratory CO, 2014) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K061974.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze 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, PCO 2 , P 0 2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2 Hb, COHb, MetHb, HHb) parameters. Total bilirubin…
Read the full statement (327 words)
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze 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, PCO 2 , P 0 2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2 Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. 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. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hemnatocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metabolites, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112995: Gem Premier 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112995
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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