510(k) · Cleared
ClearedNihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · DPS Electrocardiograph
Cleared on Aug 20, 1997 as substantially equivalent to K865032 (Nihon Kohden America, Inc., 1987) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Aug 20, 1997
- Review
- 61 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K865032 (1987). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK865032 Cardiofax-V Ecg-834OANihon Kohden America, Inc. · 1987
- This deviceK972310 Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden…Nihon Kohden America, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK072060 QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax VNihon Kohden America, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K072060QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax VNihon Kohden America, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K865032 | Cardiofax-V Ecg-834OA | Nihon Kohden America, Inc. | 1987 | — |
| 0 (this device) | K972310 | Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a… | Nihon Kohden America, Inc. | 1997 | — |
| +1 | K072060 | QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax V | Nihon Kohden America, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K865032 | Cardiofax-V Ecg-834OASummary page 1…2E Exercise Test Option include Electrocardiograph and Cardiograph. The predicate devices are the Nihon Kohden Cardiofax, Model ECG-8340A Electrocardiograph per 510(k) #K865032, commercial distribution certification dated March 10, 1987 and the Quinton Instrument Company Model Q710 Exercise and Resting EC… | 1987 |
| * | K945626 | Quinton Model 710 Stress ElectrocardiographSummary page 1…per 510(k) #K865032, commercial distribution certification dated March 10, 1987 and the Quinton Instrument Company Model Q710 Exercise and Resting ECG System per 510(k) #K945626, commercial distribution certification dated June 28, 1995. The QP-932E Exercise Test Option with its parent device, the Nihon… | 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 |
|---|---|---|---|
| K072060 | QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax V | 2007 | 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 DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 QP-932E Exercise Test Option with its parent device, the Nihon Kohden Cardiofax ECG-9320A Electrocardiograph, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-932E will develop a report based upon acquired data and subsequent calculations.
The ECG-9320A with QP-932E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.
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/K972310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972310: Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972310
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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