510(k) · Cleared
ClearedICA1 Ionized Calcium Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The London Co. · JFP Electrode, Ion Specific, Calcium
Cleared on Oct 31, 1980 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Oct 31, 1980
- Review
- 88 days
- Class
- Class II
- Product code
- JFP
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK801848 ICA1 Ionized Calcium AnalyzerThe London Co. · 1980
- Descendant · cites it directly · 20 of its ownK963800 IL SynthesisInstrumentation Laboratory CO · 1996
- Descendant · 2 generations on · 18 of its ownK992834 Gem Premier 3000Instrumentation Laboratory CO · 1999 · Recalled
- Descendant · 3 generations on · 17 of its ownK022158 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP…Instrumentation Laboratory CO · 2002
- Descendant · 4 generations on · 16 of its ownK052121 Gem Premier 3000Instrumentation Laboratory CO · 2005 · Recalled
- Descendant · 2 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
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K963800IL SynthesisInstrumentation Laboratory CO · 1996 · cites it directly20descendants
- K992834Gem Premier 3000Instrumentation Laboratory CO · 1999 · 2 generations on18descendants
- K022158Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration…Instrumentation Laboratory CO · 2002 · 3 generations on17descendants
- K052121Gem Premier 3000Instrumentation Laboratory CO · 2005 · 4 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 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K801848 | ICA1 Ionized Calcium Analyzer | The London Co. | 1980 | — |
| +1 | K963800 | IL Synthesis | Instrumentation Laboratory CO | 1996 | — |
| +2 | K992834 | Gem Premier 3000 | Instrumentation Laboratory CO | 1999 | 5 |
| +3 | K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration… | Instrumentation Laboratory CO | 2002 | — |
| +4 | K052121 | Gem Premier 3000 | Instrumentation Laboratory CO | 2005 | 2 |
| +2 | K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with CO-OX; Gem CVP 3… | Instrumentation Laboratory CO | 2006 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JFP? 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 JFP device
- #1 K230300 i-STAT CG8+ cartridge with the i-STAT 1 Systemscore 6.8 · 3 generations · no Class I recall
- #2 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? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963800 | IL Synthesis | 1996 | 20 |
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, K963800 (Instrumentation Laboratory CO, 1996) has gone furthest, with 20 descendants of its own.
How does its category compare?
All JFP devicesJFP Electrode, Ion Specific, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JFP
Too few JFP 510(k)s in any year since 2007 to give a median.
Recalls per year · JFP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFP
40in 2025
MAUDE reports naming product code JFP, 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 | — | 1 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K801848 · printed Nov 5, 2026
Cite this page
510(k) Report. “K801848: ICA1 Ionized Calcium Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K801848
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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