510(k) · Cleared
ClearedDuo-Max Blood Pressure & Glucose Monitor HMF-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hubdic Co., Ltd. · CGA Glucose Oxidase, Glucose
Cleared on Feb 13, 2009 as substantially equivalent to K052108 (Sein Electronics Co., Ltd., 2005) and 1 other predicate after a 344-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Feb 13, 2009
- Review
- 344 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K021239 (2002). 14 ancestors in all, the oldest K942455 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK021239 Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 2002
- 3 generations backK040159 Apm Blood Pressure Monitor, Model BP108AAsia Pacific Microsystems, Inc. · 2004
- 2 generations backK042795 Clever Chek TD-3213Taidoc Technology Corporation · 2005
- 1 generation backK052108 Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005
- This deviceK080636 Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021239 | Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M | Eikon Healthcare Device Corp. | 2002 | — |
| −3 | K040159 | Apm Blood Pressure Monitor, Model BP108A | Asia Pacific Microsystems, Inc. | 2004 | — |
| −2 | K042795 | Clever Chek TD-3213 | Taidoc Technology Corporation | 2005 | — |
| −1 | K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 | Sein Electronics Co., Ltd. | 2005 | — |
| 0 (this device) | K080636 | Duo-Max Blood Pressure & Glucose Monitor HMF-100 | Hubdic Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Summary page 1…NBW, CGA, JJX, DXN 3. Predicate Device: Blood Glucose and Blood Pressure Monitor System, Model BGP-100 Sein Electronics Co., Ltd K052108 Infopia GlucolabTM Blood Glucose Monitoring System K051285 4. Description: HuBDIC's Duo- Max Blood Pres… | 2005 |
| * | K051285 | Glucolab Blood Glucose Monitoring SystemSummary page 1…Blood Glucose and Blood Pressure Monitor System, Model BGP-100 Sein Electronics Co., Ltd K052108 Infopia GlucolabTM Blood Glucose Monitoring System K051285 4. Description: HuBDIC's Duo- Max Blood Pressure and Glucose Monitor System, Model HMF-100 combines the… | 2005 |
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?
- The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K052108.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Blood pressure and glucose monitor, Duo-MaxTM consists'of a meter with wrist cuff and glucose test strips. The glucose test system is intended for use in the quantitative measurement of glucose in capillary whobl blood taken from.the fingertip, dorsal hand, ventral palm, upper arm, forearn, calf and thigh. Glucose testing is- done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals. Glucose testing system…
Read the full statement (125 words)
The Blood pressure and glucose monitor, Duo-MaxTM consists'of a meter with wrist cuff and glucose test strips. The glucose test system is intended for use in the quantitative measurement of glucose in capillary whobl blood taken from.the fingertip, dorsal hand, ventral palm, upper arm, forearn, calf and thigh. Glucose testing is- done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals. Glucose testing system is not to be used for the diagnosis or screening of diabetes. It is not intended for use on neonates. Also the blood pressure test system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillomentric metric method of measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080636 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080636: Duo-Max Blood Pressure & Glucose Monitor HMF-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080636
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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