510(k) · Cleared
Recalled · 2011Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4 Hematocrit
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 Sep 15, 2006 as substantially equivalent to K052121 (Instrumentation Laboratory CO, 2005) and 2 other predicates after a 65-day review. Its family tree reaches back 5 generations to 1980. 14 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 15, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 5 generations to K801848 (1980). 10 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 4 generations backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- 3 generations backK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- 2 generations backK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- 1 generation backK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- This deviceK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006
- Descendant · cites it directly · 12 of its ownK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- Descendant · cites it directly · 11 of its ownK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- Descendant · 2 generations on · 10 of its ownK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- Descendant · 3 generations on · 2 of its ownK173403 GEM Premier 5000Instrumentation Laboratory CO · 2017
- Descendant · 2 generations on · 2 of its ownK160225 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride…Instrumentation Laboratory CO · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO · 2010 · cites it directly12descendants
- K112995Gem Premier 4000Instrumentation Laboratory CO · 2012 · cites it directly11descendants
- K133407Gem Premier 4000Instrumentation Laboratory CO · 2014 · 2 generations on10descendants
- K173403GEM Premier 5000Instrumentation Laboratory CO · 2017 · 3 generations on2descendants
- K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…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 |
|---|---|---|---|---|---|
| −5 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −4 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| −3 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| −2 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| −1 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| 0 (this device) | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | — |
| +1 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| +1 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| +2 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| +3 | K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017 | — |
| +2 | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized… | Instrumentation Laboratory CO | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K052121 | Gem Premier 3000Summary page 2…Analytes pH, blood gases, electrolytes (except GEM 3000 with iQM and GEM CVP K052121 chloride), glucose, lactate, hematocrit IL Synthesis with traditional QC K963800 Chloride IL 682 CO-Oxim… | 2005 |
| * | K963800 | IL SynthesisSummary page 2…, electrolytes (except GEM 3000 with iQM and GEM CVP K052121 chloride), glucose, lactate, hematocrit IL Synthesis with traditional QC K963800 Chloride IL 682 CO-Oximeter with traditional QC K945677 CO-Oximeter parameters Device Description and Indicati… | 1996 |
| * | K945677 | IL682, CO-OximeterSummary page 2…K052121 chloride), glucose, lactate, hematocrit IL Synthesis with traditional QC K963800 Chloride IL 682 CO-Oximeter with traditional QC K945677 CO-Oximeter parameters Device Description and Indications for Use: The GEM Premier 4000 is a portable critical care system… | 1995 |
What descends from it? (14)
See all 143 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2011 | Not classified | Z-2806-2011 | Nonconforming Material/Component | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| May 31, 2011 | Not classified | Z-2805-2011 | Nonconforming Material/Component | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| May 31, 2011 | Not classified | Z-2803-2011 | Nonconforming Material/Component | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| Mar 27, 2007 | Not classified | Z-0778-2007 | Other | Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K093623 (Instrumentation Laboratory CO, 2010) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K052121.
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.
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 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, pCO2, PO2, Na +, K +, CI-, Ca ++, glucose, lactate, hematocrit and CO-Oximetry (tHb, O 2Hb, COHb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the…
Read the full statement (252 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, pCO2, PO2, Na +, K +, CI-, Ca ++, glucose, lactate, hematocrit and CO-Oximetry (tHb, O 2Hb, COHb, MetHb, HHb) parameters. 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.
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.
As part of this program, GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet 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/K061974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061974: Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4 Hematocrit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061974
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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