510(k) Report

510(k) · Cleared

Cleared

Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive Predicitive Instrument (Aci-Tipt)

K951978510(k) TraditionalCleared Jan 4, 1996252-day review

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 1998: 2 descendants cleared1995200020052010201520202025
  1. This deviceK951978 Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive…Hewlett-Packard Co. · 1996
  2. Descendant · cites it directly · 1 of its ownK981265 Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute…Hewlett-Packard Co. · 1998
  3. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951978Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive…Hewlett-Packard Co.1996—
+1K981265Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac…Hewlett-Packard Co.1998—
+2K982025Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100…Hewlett-Packard Co.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
FIG. 1 — Lineage of K951978, 1996–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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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.

NumberDeviceApplicantDecidedDescendants
K981265Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time…Hewlett-Packard Co.19981

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.
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