510(k) · Cleared
ClearedMeca Wrist Blood Pressure Meter, Model EW243 and Model EW254
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matsushita Electric Corp. of America · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Apr 10, 2000 as substantially equivalent to K942422 (King & Spalding, 1995) after a 350-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Apr 10, 2000
- Review
- 350 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942422 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK942422 Panasonic Wrist Blood Pressure MeterKing & Spalding · 1995
- This deviceK991458 Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254Matsushita Electric Corp. of America · 2000
- Descendant · cites it directly · 0 of its ownK033894 Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032Matsushita Electric Works, Ltd. · 2004
Most influential descendants
Showing 1 of 1 · See all- K033894Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032Matsushita Electric Works, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942422 | Panasonic Wrist Blood Pressure Meter | King & Spalding | 1995 | — |
| 0 (this device) | K991458 | Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254 | Matsushita Electric Corp. of America | 2000 | — |
| +1 | K033894 | Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 | Matsushita Electric Works, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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 |
|---|---|---|---|
| * | K942422 | Panasonic Wrist Blood Pressure MeterSummary page 2…ystems Device Panel Product code: 74 DXN 1. Iv. VI PREDICATE DEVICE In 1995, MECA’s wrist blood pressure monitor model EW277 was cleared for market (K942422). A. Name of Predicate Devices Panasonic wrist blood pressure monitor, model EW277. B. Intended Use The wrist blood pressure mo… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033894 | Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 | 2004 | 0 |
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?
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?
Model EW243 and model EW254 are intended to be used for the oscillometric PRECISE LOGIC™ measurement of systolic and diastolic blood pressure and pulse rate using a pressurized cuff.
These devices are designed for use by adults. These devices should not be used on infants or toddlers, for continuous monitoring during medical emergencies or operations, or for amy other purpose other than measuring blood pressure.
Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American Nationmal Standard, Electronic or Automated Sphygmomanometers.
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/K991458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991458: Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991458
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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