510(k) · Cleared
Recalled · Class II · 2023Gem Premier 3000
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 Nov 24, 1999 as substantially equivalent to K963800 (Instrumentation Laboratory CO, 1996) after a 93-day review. Its family tree reaches back 2 generations to 1980. 18 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 24, 1999
- Review
- 93 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801848 (1980). 6 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- 1 generation backK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- This deviceK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999
- Descendant · cites it directly · 17 of its ownK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- Descendant · 2 generations on · 16 of its ownK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- Descendant · 3 generations on · 14 of its ownK061974 Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX…Instrumentation Laboratory CO · 2006 · Recalled
- Descendant · 4 generations on · 12 of its ownK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- Descendant · 4 generations on · 11 of its ownK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K022158Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration…Instrumentation Laboratory CO · 2002 · cites it directly17descendants
- K052121Gem Premier 3000Instrumentation Laboratory CO · 2005 · 2 generations on16descendants
- K061974Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3 and 4…Instrumentation Laboratory CO · 2006 · 3 generations on14descendants
- K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO · 2010 · 4 generations on12descendants
- K112995Gem Premier 4000Instrumentation Laboratory CO · 2012 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| −1 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| 0 (this device) | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | — |
| +1 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| +2 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| +3 | 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 |
| +4 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 5 | 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 14.2 · 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? (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 |
|---|---|---|---|
| * | K963800 | IL SynthesisSummary page 1…862.1145 Calcium test system Class 11 81GKF Instrument, hematocrit, automated 864.5600 Automated hematocrit instrument Class I Identification of predicate device(s): K963800 IL Synthesis (except for hematocrit, which used manual spun hematocrit) Description of the device/intended use(s): The GEM Prem… | 1996 |
| * | — | manual spun hematocrit Named without a submission number |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | 2002 | 17 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2023 | Class II | Z-0357-2024 | Under Investigation by firm | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications… |
| Sep 29, 2023 | Class II | Z-0358-2024 | Under Investigation by firm | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications… |
| Sep 29, 2023 | Class II | Z-0359-2024 | Under Investigation by firm | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications… |
| Mar 7, 2003 | Not classified | Z-0846-03 | Other | Incorrect bar code applied to cartridges could result in inaccurate pO2 value |
| Mar 7, 2003 | Not classified | Z-0845-03 | Other | Incorrect bar code applied to cartridges could result in inaccurate pO2 value |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 16.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K022158 (Instrumentation Laboratory CO, 2002) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K963800.
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 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO,, pO,, Na+, K+, Ca++, and Het. These parameters along with derived parameters Base Excess, HCO;, TCO, and sO, aid in the diagnosis of a patient’s acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
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/K992834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992834: Gem Premier 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992834
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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