510(k) · Cleared
ClearedQuinton Model Q710 Exercise and Resting Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Jul 31, 1996 after a 140-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 31, 1996
- Review
- 140 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | Hewlett Packard Pagewriter XLi M1700A Named without a submission number |
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 is it indicated for?
The intended uses of the Quinton Model Q710 Exercise and Resting Electrocardiograph are acquisition, digitization, display, and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data.
As an option, the Model Q710 has a resting ECG analysis program which makes measurements and provides interpretation of the ECG waveform for both adult and pediatric populations. This analysis program is offered to the physician on an advisory basis only and the physician is asked to overread and validate (or change) the ECG interpretation.
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/K961014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961014: Quinton Model Q710 Exercise and Resting Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961014
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026