510(k) · Cleared
ClearedIL Synthesis
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 13, 1996 as substantially equivalent to K890827 (Instrumentation Laboratory CO, 1989) and 4 other predicates after a 51-day review. Its family tree reaches back 1 generation to 1980. 20 later devices descend from it.
- Decided
- Nov 13, 1996
- Review
- 51 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K801848 (1980). 5 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- This deviceK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- Descendant · cites it directly · 18 of its ownK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- Descendant · 2 generations on · 17 of its ownK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- Descendant · 3 generations on · 16 of its ownK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- Descendant · cites it directly · 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 · 2 generations on · 12 of its ownK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K992834Gem Premier 3000Instrumentation Laboratory CO · 1999 · cites it directly18descendants
- K022158Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration…Instrumentation Laboratory CO · 2002 · 2 generations on17descendants
- K052121Gem Premier 3000Instrumentation Laboratory CO · 2005 · 3 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 · cites it directly14descendants
- K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO · 2010 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| 0 (this device) | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| +1 | 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 | — |
| +3 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| +1 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
| +2 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K890827 | IL1400, Bgelectrolyte AnalyzerSummary page 2…Calibrator Quality control material (assayed and unassayed) Hematology quality control mixture Identification of predicate device(s): IL 1400 BGElectrolyte Analyzer K890827/A IL 1430 BGElectrolyte Analyzer K935069/S2 IL BGGE Blood Gas with Glucose Analyzer K955793 [L 682 CO-Oximetet K945677/S2 Rad… | 1989 |
| * | K935069 | IL1430 Bgelectrolyte AnalyzerSummary page 2…ayed and unassayed) Hematology quality control mixture Identification of predicate device(s): IL 1400 BGElectrolyte Analyzer K890827/A IL 1430 BGElectrolyte Analyzer K935069/S2 IL BGGE Blood Gas with Glucose Analyzer K955793 [L 682 CO-Oximetet K945677/S2 Radiometer ICA?2 lonized Calcium Analyzer K80… | 1994 |
| * | K955793 | IL Bgge Blood Gas with Glucose SystemSummary page 2…ure Identification of predicate device(s): IL 1400 BGElectrolyte Analyzer K890827/A IL 1430 BGElectrolyte Analyzer K935069/S2 IL BGGE Blood Gas with Glucose Analyzer K955793 [L 682 CO-Oximetet K945677/S2 Radiometer ICA?2 lonized Calcium Analyzer K801848 Section 3 IL Synthesis S10(k) Class I Class |… | 1996 |
| * | K945677 | IL682, CO-OximeterSummary page 2…cate device(s): IL 1400 BGElectrolyte Analyzer K890827/A IL 1430 BGElectrolyte Analyzer K935069/S2 IL BGGE Blood Gas with Glucose Analyzer K955793 [L 682 CO-Oximetet K945677/S2 Radiometer ICA?2 lonized Calcium Analyzer K801848 Section 3 IL Synthesis S10(k) Class I Class | Class 1 Class 11 Class 1… | 1995 |
| * | K801848 | ICA1 Ionized Calcium AnalyzerSummary page 2…7/A IL 1430 BGElectrolyte Analyzer K935069/S2 IL BGGE Blood Gas with Glucose Analyzer K955793 [L 682 CO-Oximetet K945677/S2 Radiometer ICA?2 lonized Calcium Analyzer K801848 Section 3 IL Synthesis S10(k) Class I Class | Class 1 Class 11 Class 11 Class 11 Class 11 Class I1 Class 1 Class I Page… | 1980 |
What descends from it? (20)
See all 203 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?
- None of the 5 ancestors has a recall.
- Of its descendants, K992834 (Instrumentation Laboratory CO, 1999) has gone furthest, with 18 descendants of its own.
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 IL Synthesis (hardware, software, and reagents) is for the quantitative in vitro diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (Cl-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selective electrode (ISE)…
Read the full statement (163 words)
The IL Synthesis (hardware, software, and reagents) is for the quantitative in vitro diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (Cl-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selective electrode (ISE) potentiometry. Sodium and potassium results are used to monitor electrolyte balance. Note that the number of electrodes is limited and any given instrument will only contain two of the three functions: calcium (Ca++), chloride (Cl-) and Glucose (Glu).
The IL Synthesis (hardware, software, and reagents) also permits the quantitative in vitro diagnostic determination of five forms of hemoglobin in whole blood samples, total hemoglobin (tHb), oxyhemoglobin (%O2Hb), carboxyhemoglobin (%COHb), methemoglobin (MetHb) and reduced hemoglobin, also called deoxyhemoglobin (%RHb) and will also calculate the following parameters: oxygen content of hemoglobin (O2ct), oxygen binding capacity (O2cap) and oxygen saturation (sO2).
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/K963800 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963800: IL Synthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963800
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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