510(k) · Cleared
ClearedFuzzy Automatic Blood Pressure Monitor Models MD-750, MD-770, MD-800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditec Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 21, 1999 as substantially equivalent to K952826 (Sein Electronics Co., Ltd., 1996) after a 9-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Jul 21, 1999
- Review
- 9 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952826 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952826 Full Auto Fuzzy Blood Pressure Meter Model SE-7000Sein Electronics Co., Ltd. · 1996
- This deviceK992328 Fuzzy Automatic Blood Pressure Monitor Models MD-750, MD-770, MD-800Meditec Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK041491 Zewa MFM-007 Blood Pressure MonitorZewa, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK041789 Noninvasive Blood Pressure Monitor, Models MD-880B and MD-900TMeditec Co., Ltd. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952826 | Full Auto Fuzzy Blood Pressure Meter Model SE-7000 | Sein Electronics Co., Ltd. | 1996 | — |
| 0 (this device) | K992328 | Fuzzy Automatic Blood Pressure Monitor Models MD-750, MD-770, MD-800 | Meditec Co., Ltd. | 1999 | — |
| +1 | K041491 | Zewa MFM-007 Blood Pressure Monitor | Zewa, Inc. | 2004 | — |
| +1 | K041789 | Noninvasive Blood Pressure Monitor, Models MD-880B and MD-900T | Meditec Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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 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 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K952826 | Full Auto Fuzzy Blood Pressure Meter Model SE-7000Summary page 1…r Model MD-800 b. Common Name and Classification Name : Noninvasive Blood Pressure Measurement System. 3. PREDICATE DEVICE. Sein Blood Pressure Meters, Models SE-7000, K952826 4. DEVICE DESCRIPTION. a. General : Three Meditec models are oscillometric systems intended for measurement of blood pressure a… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K041491 (Zewa, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXN devicesDXN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
Noninvasive measurement of systolic and diastolic' blood pressure and heart rate in adult patients, i.e., age 18 and above, in a home care environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992328: Fuzzy Automatic Blood Pressure Monitor Models MD-750, MD-770, MD-800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992328
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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