510(k) · Cleared
ClearedGenchem CO2 Acid Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genchem, Inc. · JFL Ph Rate Measurement, Carbon-Dioxide
Cleared on Dec 27, 2004 as substantially equivalent to K014034 (Beckman Coulter, Inc., 2001) after a 257-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Dec 27, 2004
- Review
- 257 days
- Class
- Class II
- Product code
- JFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883181 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
- 2 generations backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
- 1 generation backK014034 Modification to Synchron LX Clinical Chemistry Systems (LX20 and…Beckman Coulter, Inc. · 2001 · Recalled
- This deviceK040975 Genchem CO2 Acid ReagentGenchem, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer Reage | Beckman Instruments, Inc. | 1988 | 2 |
| −2 | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… | Beckman Instruments, Inc. | 1997 | 12 |
| −1 | K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro) | Beckman Coulter, Inc. | 2001 | 4 |
| 0 (this device) | K040975 | Genchem CO2 Acid Reagent | Genchem, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 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 JFL? 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 JFL device
- #1 K191298 i-STAT CHEM8+ cartridge with the i-STAT 1 Systemscore 2.4 · 3 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)Summary page 1…optimum system operation. 5.0 Substantial Equivalence Information: a. Predicate Device Name: Beckman C02 Reagent for the CX3. b. Predicate K Number: K014034 c. Comparison with Predicate: Both Reagents are similar in design, function and chemical principle as well as… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 5 of the 6 ancestors have a recall of any class.
How does its category compare?
All JFL devicesJFL Ph Rate Measurement, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFL
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JFL
Too few JFL 510(k)s in any year since 2007 to give a median.
Recalls per year · JFL
No recall names JFL since 2007.
Adverse event reports per year · JFL
2in 2011
MAUDE reports naming product code JFL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GenChem CO 2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem C02 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acid-base balance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040975: Genchem CO2 Acid Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040975
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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