510(k) · Cleared
ClearedArkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray Factory, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jun 30, 2014 as substantially equivalent to K073416 (Arkray Factory USA, Inc., 2008) after a 550-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.
- Decided
- Jun 30, 2014
- Review
- 550 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K073416 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK073416 Arkray Glucocard 01 Blood Monitoring SystemArkray Factory USA, Inc. · 2008
- This deviceK124021 Arkray Glucocard 01 Blood Glucose Monitoring System and Relion…Arkray Factory, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK142336 GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood…Arkray Factory, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring…Arkray Factory, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073416 | Arkray Glucocard 01 Blood Monitoring System | Arkray Factory USA, Inc. | 2008 | — |
| 0 (this device) | K124021 | Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood… | Arkray Factory, Inc. | 2014 | — |
| +1 | K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose… | Arkray Factory, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K073416 | Arkray Glucocard 01 Blood Monitoring SystemSummary page 1…Glucose test system, 21 CFR 862.1345; Class 11 Product Codes: CGA, NBW Predicate Device: GLUCOCARD 01 Blood Glucose Monitoring System (K0734 16) Device Description: The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confir… | 2008 |
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 |
|---|---|---|---|
| K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring… | 2014 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K142336 (Arkray Factory, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for…
Read the full statement (265 words)
The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 SENSOR Plus Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be used with the ReliOn Confirm Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124021: Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124021
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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