510(k) · Cleared
Recalled · Class II · 2025Easystat PH, PCO2, PO2, HCT, NA+, K+, CA++ Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jul 16, 2002 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 16, 2002
- Review
- 67 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK021515 Easystat PH, PCO2, PO2, HCT, NA+, K+, CA++ AnalyzerMedica Corp. · 2002
- Descendant · cites it directly · 0 of its ownK211559 EasyStat 300Medica Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K211559EasyStat 300Medica Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021515 | Easystat PH, PCO2, PO2, HCT, NA+, K+, CA++ Analyzer | Medica Corp. | 2002 | — |
| +1 | K211559 | EasyStat 300 | Medica Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211559 | EasyStat 300 | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 31, 2025 | Class II | Z-1370-2026 | Nonconforming Material/Component | A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211559 (Medica Corporation, 2023) has gone furthest, with 0 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 EasyStat analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PC02 (partial pressure of carbon dioxide), PO2 (partial pressure of oxygen),Hct (Hematocrit), Na' (sodium), K' (potassium), and ea++ (ionized calcium) on whole blood samples from syringes or capillary tubes.
This analyzer is used by laboratory trained technicians in the clinical laboratories to aide in the diagnosis and treatment of patients with electrolyte, blood gas and/or acid base disturbances. The patient results obtained from the EasyStat analyzer must be used in conjunction with the overall a1 condition before corrective / therapeutic action is taken.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021515 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021515: Easystat PH, PCO2, PO2, HCT, NA+, K+, CA++ Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021515
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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