510(k) · Cleared
ClearedEasystat PH, PCO2, PO2, HTC, NA, K, CL 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 Jun 25, 2007 after a 229-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 25, 2007
- Review
- 229 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 14.1 · 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?
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.
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. 2007, this device’s year, is highlighted.
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 pH, PCO2, P02, Htc, Na, K,Ca/Cl analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO 2 (partial pressure of carbon dioxide), P0 2 (partial pressure of oxygen), Htc (Hematocrit), Nat (sodium ions), K+ (potassium ions), Catt (ionized calcium) and cr (chloride ions) in whole blood samples from syringes or capillary tubes. pH measurements are used in the diagnosis and treatment of…
Read the full statement (209 words)
The EasyStat pH, PCO2, P02, Htc, Na, K,Ca/Cl analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO 2 (partial pressure of carbon dioxide), P0 2 (partial pressure of oxygen), Htc (Hematocrit), Nat (sodium ions), K+ (potassium ions), Catt (ionized calcium) and cr (chloride ions) in whole blood samples from syringes or capillary tubes.
pH measurements are used in the diagnosis and treatment of diseases involving imbalance in the acid-base equilibrium in blood.
PCO2 measurements are used inthe diagnosis and treatment of diseases involving imbalance inthe partial pressure of carbon dioxide in blood.
P02 measurements are used in the diagnosis and treatment of diseases conditions characterized by low or high blood oxygen levels in blood.
Hematotric (Htc) measurements are used in the diagnosis and treatment of diseases characterized by erythrocyte imbalances in whole blood.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium (ionized) measurements are used to determine the physiologically active form of calcium in blood and establish the patient's calcium metabolism.
Chloride measurements are used inthe diagnosis and treatment of electrolyte and metabolic disorders.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063376: Easystat PH, PCO2, PO2, HTC, NA, K, CL Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063376
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026