510(k) · Cleared
ClearedCardiMax Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · DPS Electrocardiograph
Cleared on Apr 16, 2018 as substantially equivalent to K981066 (Fukuda Denshi USA, Inc., 1998) and 1 other predicate after a 195-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Apr 16, 2018
- Review
- 195 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913811 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913811 Fukuda Denshi Model FCP-4101Fukuda Denshi USA, Inc. · 1991
- 2 generations backK971440 Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive…Fukuda Denshi USA, Inc. · 1997
- 1 generation backK981066 Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel…Fukuda Denshi USA, Inc. · 1998
- This deviceK173226 CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913811 | Fukuda Denshi Model FCP-4101 | Fukuda Denshi USA, Inc. | 1991 | — |
| −2 | K971440 | Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive Electrocardiograph | Fukuda Denshi USA, Inc. | 1997 | — |
| −1 | K981066 | Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph | Fukuda Denshi USA, Inc. | 1998 | — |
| 0 (this device) | K173226 | CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K981066 | Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel ElectrocardiographSummary page 4…II • Review Panel: Cardiovascular Predicate Devices: Fukuda Denshi Cardiograph Model FX-4010 Electrocardiograph, 510(k) # K981066. The 12-Lead ECG analysis software module which modified any functions used in the FX-8322 is… | 1998 |
| * | K072217 | Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MSummary page 4…10 Multi Channel Electrocardiograph cleared under 510(k) # K981066 and the Nihon Kohden Cardiofax model ECG-1350A cleared under 510(k) #K072217. FX-8322 510(k) 510(k) Summary… | 2007 |
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 27 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K981066.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. The basic system delivers three (3), six (6) or twelve (12) channels of ECG parameters (waveform, arrhythmia and rhythm measurements, interpretation and heart rate). The device is indicated in situations where an instantaneous display of ECG information or a hard copy record may be required. The device is intended to be used under the direct supervision or a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173226: CardiMax Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173226
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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