510(k) · Cleared
ClearedHewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive Predicitive Instrument (Aci-Tipt)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · LOS (no longer in FDA’s product-code list)
Cleared on Jan 4, 1996 after a 252-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jan 4, 1996
- Review
- 252 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK951978 Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive…Hewlett-Packard Co. · 1996
- Descendant · cites it directly · 1 of its ownK981265 Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute…Hewlett-Packard Co. · 1998
- Descendant · 2 generations on · 0 of its ownK982025 Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100…Hewlett-Packard Co. · 1998
Most influential descendants
Showing 2 of 2 · See all- K981265Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time…Hewlett-Packard Co. · 1998 · cites it directly1descendant
- K982025Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/DefibrillatorHewlett-Packard Co. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951978 | Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive… | Hewlett-Packard Co. | 1996 | — |
| +1 | K981265 | Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac… | Hewlett-Packard Co. | 1998 | — |
| +2 | K982025 | Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100… | Hewlett-Packard Co. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981265 | Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time… | 1998 | 1 |
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, K981265 (Hewlett-Packard Co., 1998) has gone furthest, with 1 descendant of its own.
https://510kreport.com/device/K951978 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951978: Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive Predicitive Instrument (Aci-Tipt).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951978
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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