510(k) · Cleared
ClearedI-Stat 1 Wireless Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Point of Care, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Feb 8, 2011 as substantially equivalent to K001387 (I-Stat Corp., 2000) after a 102-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it.
- Decided
- Feb 8, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001387 (2000). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
- This deviceK103195 I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK163342 i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories · 2017
- Descendant · 2 generations on · 4 of its ownK183680 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK210958 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK223755 i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK252488 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories · 2017 · cites it directly5descendants
- K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on4descendants
- K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021 · 3 generations on3descendants
- K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 4 generations on1descendant
- K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001387 | I-Stat Portable Clinical Analyzer, Model 300 | I-Stat Corp. | 2000 | 13 |
| 0 (this device) | K103195 | I-Stat 1 Wireless Analyzer | Abbott Point of Care, Inc. | 2011 | — |
| +1 | K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories | 2017 | — |
| +2 | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +3 | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021 | — |
| +4 | K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
| +5 | K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K001387 | I-Stat Portable Clinical Analyzer, Model 300 | 2000 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and…
Read the full statement (608 words)
The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.
* Sodium measurements are used for monitoring electrolyte imbalances.
* Potassium measurements are used for diagnosis and monitoring of diseases and clinical conditions that manifest high and low Potassium levels.
* Chloride measurements are primarily used in the diagnosis, monitoring and treatment of electrolyte and metabolic disorders including but not limited to cystic fibrosis, diabetic acidosis and hydration disorders.
* Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
* Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
* Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of certain renal and metabolic diseases.
* Ionized calcium measurements are used in the diagnosis, monitoring and treatment of conditions including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
* pH-, pCO2 and p02 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-base disturbances.
* Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
* The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
* The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
* The i-STAT PT, a prothrombin time test, is useful in monitory patients receiving oral anticoagulation therapy such as Coumnadin or warfarin.
* Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
* The i-STAT Cardiac Troponin I (cTnI) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
* The i-STAT CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB; measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
* The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
* The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103195: I-Stat 1 Wireless Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103195
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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