510(k) · Cleared
Recalled · 2011EML105 Electrolyte Metabolite Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer America, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Oct 24, 1996 as substantially equivalent to K952621 (Radiometer America, Inc., 1995) after a 129-day review. Its family tree reaches back 1 generation to 1995. 45 later devices descend from it. It has been recalled once.
- Decided
- Oct 24, 1996
- Review
- 129 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952621 (1995). 45 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952621 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1995
- This deviceK962334 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1996
- Descendant · cites it directly · 44 of its ownK980130 ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 3 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 4 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · 2 generations on · 16 of its ownK991417 Abl 735 AnalyzerRadiometer America, Inc. · 1999 · Recalled
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K980130ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · cites it directly44descendants
- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · 2 generations on31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 3 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 4 generations on18descendants
- K991417Abl 735 AnalyzerRadiometer America, Inc. · 1999 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952621 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1995 | — |
| 0 (this device) | K962334 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1996 | — |
| +1 | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System | Radiometer America, Inc. | 1998 | 5 |
| +2 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +4 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +2 | K991417 | Abl 735 Analyzer | Radiometer America, Inc. | 1999 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 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 |
|---|---|---|---|
| * | K952621 | EML105 Electrolyte Metabolite AnalyzerSummary page 1…BSTANTIAL EQUIVALENCE: EML105 with lactate is substantially equivalent in features and characteristics to the current version EML105 marketed by Radiometer America Inc. (K952621). The only difference is the addition of the lactate analyte. Like the current version of EML105, the EMLI105 with lactate can be… | 1995 |
| * | — | YSI 2300 Named without a submission number |
What descends from it? (45)
See all 451 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System | 1998 | 44 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2011 | Not classified | Z-2571-2011 | Pending | Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K980130 (Radiometer America, Inc., 1998) has gone furthest, with 44 descendants of its own.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
EML105 is a stand alone, electrolyte metabolite analyzer that measures Na*, K*, Ca®>*, CI, glucose and lactate on whole blood and urine. It can be interfaced with an ABL analyzer 500/510/520 to become an ABL System 605/615/625 for the measurement of pH/Blood gases, electrolytes, metabolites and co-oximetry.
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/K962334 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962334: EML105 Electrolyte Metabolite Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962334
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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