510(k) · Cleared
ClearedGem Premier 3000- Addition of Glucose and Lactate as New Parameters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · CGA Glucose Oxidase, Glucose
Cleared on May 7, 2001 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- May 7, 2001
- Review
- 74 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK010520 Gem Premier 3000- Addition of Glucose and Lactate as New ParametersInstrumentation Laboratory CO · 2001
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K010520 | Gem Premier 3000- Addition of Glucose and Lactate as New Parameters | Instrumentation Laboratory CO | 2001 | — |
| +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 | — |
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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022158 (Instrumentation Laboratory CO, 2002) has gone furthest, with 17 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K010520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010520: Gem Premier 3000- Addition of Glucose and Lactate as New Parameters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010520
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026