510(k) · Cleared
ClearedPanasonic Wrist Blood Pressure Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
King & Spalding · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 15, 1995 after a 271-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 15, 1995
- Review
- 271 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK942422 Panasonic Wrist Blood Pressure MeterKing & Spalding · 1995
- Descendant · cites it directly · 1 of its ownK991458 Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254Matsushita Electric Corp. of America · 2000
- Descendant · 2 generations on · 0 of its ownK033894 Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032Matsushita Electric Works, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK981431 Panasonic Wrist Blood Pressure Meter, Model EW280Panasonic Corporation (Panasonic) · 1999
- Descendant · cites it directly · 0 of its ownK981542 Panasonic Wrist Blood Pressure Meter, Model EW284Panasonic Corporation (Panasonic) · 1999
Most influential descendants
Showing 4 of 4 · See all- K991458Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254Matsushita Electric Corp. of America · 2000 · cites it directly1descendant
- K033894Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032Matsushita Electric Works, Ltd. · 2004 · 2 generations on0descendants
- K981431Panasonic Wrist Blood Pressure Meter, Model EW280Panasonic Corporation (Panasonic) · 1999 · cites it directly0descendants
- K981542Panasonic Wrist Blood Pressure Meter, Model EW284Panasonic Corporation (Panasonic) · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942422 | Panasonic Wrist Blood Pressure Meter | King & Spalding | 1995 | — |
| +1 | K991458 | Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254 | Matsushita Electric Corp. of America | 2000 | — |
| +2 | K033894 | Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 | Matsushita Electric Works, Ltd. | 2004 | — |
| +1 | K981431 | Panasonic Wrist Blood Pressure Meter, Model EW280 | Panasonic Corporation (Panasonic) | 1999 | — |
| +1 | K981542 | Panasonic Wrist Blood Pressure Meter, Model EW284 | Panasonic Corporation (Panasonic) | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 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?
- Of its descendants, K991458 (Matsushita Electric Corp. of America, 2000) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K942422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942422: Panasonic Wrist Blood Pressure Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942422
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026