510(k) Report

510(k) · Cleared

Cleared

Digibio Digtial Blood Pressure Monitor Model D11

K014141510(k) TraditionalCleared Sep 13, 2002270-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Digibio Technology Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Sep 13, 2002 after a 270-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.

Decided
Sep 13, 2002
Review
270 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2017: 1 descendant cleared2012: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared2019: 2 descendants cleared2023: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK014141 Digibio Digtial Blood Pressure Monitor Model D11Digibio Technology Corp. · 2002
  2. Descendant · cites it directly · 11 of its ownK091434 Truly Automatic Arm Blood Pressure…Truly Instrument Co., Ltd. · 2009
  3. Descendant · 2 generations on · 5 of its ownK161846 Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016
  4. Descendant · 3 generations on · 3 of its ownK192023 Arm Blood Pressure MonitorTruly Instrument Limited · 2019
  5. Descendant · 4 generations on · 2 of its ownK220113 Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd. · 2022
  6. Descendant · cites it directly · 2 of its ownK091415 Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd. · 2009

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2009: 22012: 22016: 12017: 12018: 12019: 22021: 12022: 12023: 12024: 12025: 1
2009high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 14 · See all
  • K091434Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M…Truly Instrument Co., Ltd. · 2009 · cites it directly11descendants
  • K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016 · 2 generations on5descendants
  • K192023Arm Blood Pressure MonitorTruly Instrument Limited · 2019 · 3 generations on3descendants
  • K220113Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd. · 2022 · 4 generations on2descendants
  • K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd. · 2009 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K014141Digibio Digtial Blood Pressure Monitor Model D11Digibio Technology Corp.2002—
+1K091434Truly Automatic Arm Blood Pressure…Truly Instrument Co., Ltd.2009—
+2K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited2016—
+3K192023Arm Blood Pressure MonitorTruly Instrument Limited2019—
+4K220113Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd.2022—
+1K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201220
201610
201710
201810
201920
202110
202210
202310
202410
202510
FIG. 1 — Lineage of K014141, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXN? 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 DXN device

  1. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (14)

See all 14

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091434Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M…Truly Instrument Co., Ltd.200911
K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd.20092

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?

  • Of its descendants, K091434 (Truly Instrument Co., Ltd., 2009) has gone furthest, with 11 descendants of its own.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

What is it indicated for?

DIGIBIO Digital Blood Pressure Monitor Model D11 is indicated for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user’s arm.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K014141 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014141: Digibio Digtial Blood Pressure Monitor Model D11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014141

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026