510(k) · Cleared
ClearedHL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood Glucose System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health & Life Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 25, 2012 as substantially equivalent to K062195 (Lifescan, Inc., 2006) after a 501-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- May 25, 2012
- Review
- 501 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062195 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062195 Modification to One Touch Ultra Blood Glucose Monitoring SystemLifescan, Inc. · 2006 · Recalled
- This deviceK110074 HL 568 Self Monitoring Blood Glucose System, HL 568BA…Health & Life Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062195 | Modification to One Touch Ultra Blood Glucose Monitoring System | Lifescan, Inc. | 2006 | 6 |
| 0 (this device) | K110074 | HL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood… | Health & Life Co., Ltd. | 2012 | — |
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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 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 |
|---|---|---|---|
| * | K062195 | Modification to One Touch Ultra Blood Glucose Monitoring SystemSummary page 2…II ; Class I e. Regulatory Information: 21 CFR 862.1345 ;21 CFR 862.1660 f. Panel: Clinical Chemical (75) g. Product code: NBW h. 5 10(K) Number: K062195 4. Device Description: 4.1 Blood Glucose Concentration Measurement The HL568 Self-Monitoring Blood Glucose System is comp… | 2006 |
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 a recall.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
HL568 Self-Monitoring Blood Glucose (SMBG) System is self-test medical device and intended for single patient home-use to monitor the blood glucose (P-D-glucose) levels in quantitative measurement from fresh capillary whole blood obtained from the finger tip. It is intended for use outside the body (in vitro diagnostic use) by diabetics at home to measure the glucose concentration for aiding diabetes management. It is not intended for the diagnosis of or…
Read the full statement (233 words)
HL568 Self-Monitoring Blood Glucose (SMBG) System is self-test medical device and intended for single patient home-use to monitor the blood glucose (P-D-glucose) levels in quantitative measurement from fresh capillary whole blood obtained from the finger tip. It is intended for use outside the body (in vitro diagnostic use) by diabetics at home to measure the glucose concentration for aiding diabetes management. It is not intended for the diagnosis of or screening for diabetes mellitus.
HL568 Self-Monitoring Blood Glucose (SMBG) System is intended to be used by a single person and should not be shared and it is also not intended for use on neonates and should be used with HL568 Blood glucose test strip and HL568 Control Solution.
HUGS8 Blood glucose test strips are for use with the HL568 Blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
HL568 Control Solutions are for use wit the HL568 Blood glucose meter and 11L568 Blood glucose test strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The device is capable of transferring the storage data to the connected personal computer (PC) via USH cable. In addition, HL568 Self-Monitoring Blood Glucose System is featured wit audio function; it could help the user to know the measured result by hearing but is not intended for visually impaired users.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110074: HL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood Glucose System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110074
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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