510(k) · Cleared
ClearedNihon Kohden Ecg-9320A Cardiofax and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Nov 1, 1996 as substantially equivalent to K865032 (Nihon Kohden America, Inc., 1987) and 1 other predicate after a 213-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Nov 1, 1996
- Review
- 213 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K865032 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK865032 Cardiofax-V Ecg-834OANihon Kohden America, Inc. · 1987
- This deviceK961272 Nihon Kohden Ecg-9320A Cardiofax and AccessoriesNihon Kohden America, Inc. · 1996
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) | K961272 | Nihon Kohden Ecg-9320A Cardiofax and Accessories | Nihon Kohden America, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…he ECG-9320A Cardiofax device include electrocardiograph and Cardiograph. The predicate devices are the Nihon Kohden Cardiofax, ECG-8340A Electrocardiograph per 510(k) #K865032, commercial distribution certification dated March 10, 1987 and the Hewilett-Packard M1700A PageWriter XLi Cardiograph per 510(k)… | 1987 |
| * | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701ASummary page 1…Electrocardiograph per 510(k) #K865032, commercial distribution certification dated March 10, 1987 and the Hewilett-Packard M1700A PageWriter XLi Cardiograph per 510(k) #K895520, commercial distribution certification dated July 17, 1990 Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for med… | 1990 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K865032.
What is it indicated for?
Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart. This product will be available for use by a physician within the hospital, laboratory, clinic or in a remote environment under the direct 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/K961272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961272: Nihon Kohden Ecg-9320A Cardiofax and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961272
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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