510(k) · Cleared
ClearedBlood Glucose Monitoring System (Glucose Oxidase)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philosys Co., Ltd. · CGA Glucose Oxidase, Glucose
Cleared on Mar 8, 2013 as substantially equivalent to K002134 (Selfcare, Inc., 2000) after a 455-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Mar 8, 2013
- Review
- 455 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002134 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- This deviceK113636 Blood Glucose Monitoring System (Glucose Oxidase)Philosys Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| 0 (this device) | K113636 | Blood Glucose Monitoring System (Glucose Oxidase) | Philosys Co., Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K002134 | One Touch Ultra Blood Glucose Monitoring SystemSummary page 1…sayed and unassayed) Predicate Device: We claim substantial equivalence to the OneTouch® ULTRA" System Manufactured by LifeScan, Inc., K002134. Device Description: The Ornate® VOICE Blood Glucose Monitoring System is an in vitro dia… | 2000 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 9 other devices also cite its predicate K002134.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Ornate® VOICE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by individuals with diabetes. The Ornate® VOICE Blood Glucose Monitoring System is intended to be used by a single user and should not be shared with any other…
Read the full statement (265 words)
The Ornate® VOICE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by individuals with diabetes. The Ornate® VOICE Blood Glucose Monitoring System is intended to be used by a single user and should not be shared with any other person.
The Gmate® VOICE Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Ornate® VOICE Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Ornate® VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users.
The Ornate® Blood Glucose Test Strips are for use with the Ornate® VOICE Meter for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh.
The Ornate® Control Solution is for use with the Ornate® VOICE Blood Glucose Monitoring System and is intended as a quality control measure to verify' the accuracy of your blood glucose test results and to ensure that the Ornate®&VOICE meter and Ornate® Test Strips are working properly. The Omate®) Control Solution is intended for use by people with diabetes at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113636: Blood Glucose Monitoring System (Glucose Oxidase).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113636
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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