# K170241: GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: All Medicus Co., Ltd.
- Decided: Oct 13, 2017 after 260 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010362 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083628: Glucodr Auto System, All Medicus Co., Ltd. (2009) Summary page 6.

## Indications for use
GlucoDr.S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. GlucoDr.S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S Blood Glucose Monitoring System is not for use in neonates. GlucoDr.S Blood Glucose Test Strips are for use with GlucoDr.S Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. GlucoDr.S BLE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S BLE Blood Glucose Monitoring System is not for use in neonates. GlucoDr.S BLE Blood Glucose Test Strips are for use with GlucoDr.S BLE Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. GlucoDr.S NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S NFC Blood Glucose Monitoring System is not for use in neonates. GlucoDr.S NFC Blood Glucose Test Strips are for use with GlucoDr.S NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Source page: https://510kreport.com/device/K170241
Methodology: https://510kreport.com/methodology