510(k) Report

510(k) · Cleared

Cleared

Easy Lyte Calcium Analyzer

K943091510(k) TraditionalCleared Jan 17, 1995203-day reviewClass II21 CFR 862.1145

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medica Corp. · JFP Electrode, Ion Specific, Calcium

Cleared on Jan 17, 1995 after a 203-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jan 17, 1995
Review
203 days
Class
Class II
Product code
JFP
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1995200020052010201520202025
  1. This deviceK943091 Easy Lyte Calcium AnalyzerMedica Corp. · 1995
  2. Descendant · cites it directly · 0 of its ownK012987 Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium…Phoenix Diagnostics, Inc. · 2001

Most influential descendants

Showing 1 of 1 · See all
  • K012987Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium AnalyzerPhoenix Diagnostics, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943091Easy Lyte Calcium AnalyzerMedica Corp.1995—
+1K012987Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium AnalyzerPhoenix Diagnostics, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K943091, 1995–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230300 i-STAT CG8+ cartridge with the i-STAT 1 Systemscore 6.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012987Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium AnalyzerPhoenix Diagnostics, Inc.20010

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, K012987 (Phoenix Diagnostics, Inc., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JFP devices

JFP Electrode, Ion Specific, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFP

1in 2023

2016: 12019: 12020: 12023: 1
2007high 1 (2016) · low 0 (2007)2026

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

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JFP

40in 2025

2008: 52009: 52010: 22011: 82013: 12014: 12015: 32017: 22018: 52019: 62020: 62022: 62023: 22024: 82025: 40
2007high 40 (2025) · low 0 (2007)2025

MAUDE reports naming product code JFP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—15
20090—05
20100—02
20110—18
20120—00
20130—01
20140—01
20150—03
20161—00
20170—02
20180—05
20191—06
20201—06
20210—00
20220—06
20231—02
20240—08
20250—040
20260—0—

More from Medica Corp.

47 FDA decisions under this applicant name. See the company

  • K123802Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentMedica Corp. · 2013
  • K120497Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc MaterialMedica Corp. · 20121 recall
  • K111363PPX Reagent, PPX Calibrators, PPX QC MaterialMedica Corp. · 2011
  • K111005Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialMedica Corp. · 2011
  • K112788Eastlyte NA/K/CA/PHMedica Corp. · 2011

Recent decisions in JFP

The JFP category page

  • K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
  • K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
  • K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation · 2019
  • K152327EasyLyte Na/K/Cl/Ca AnalyzerMedica Corporation · 2016
  • K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998

https://510kreport.com/device/K943091 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943091: Easy Lyte 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/K943091

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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