510(k) · Cleared
ClearedPagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time Insensitive Predictive Instrumena
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 Jun 23, 1998 as substantially equivalent to K951978 (Hewlett-Packard Co., 1996) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 23, 1998
- Review
- 77 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935772 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK935772 HP M177XA CardiographsHewlett-Packard Co. · 1994
- This deviceK981265 Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute…Hewlett-Packard Co. · 1998
- Descendant · cites it directly · 0 of its ownK982025 Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100…Hewlett-Packard Co. · 1998
Most influential descendants
Showing 1 of 1 · See all- K982025Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/DefibrillatorHewlett-Packard Co. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935772 | HP M177XA Cardiographs | Hewlett-Packard Co. | 1994 | — |
| 0 (this device) | K981265 | Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac… | Hewlett-Packard Co. | 1998 | — |
| +1 | K982025 | Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100… | Hewlett-Packard Co. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K951978 | Hewlett-Packard Model M1791A Acute Cardiac Ischemia-Time Insensitive Predicitive…Summary page 2…ly marketed devices to which equivalence is being claimed are listed below. Manufacturer Predicate Device = Model 510(k) Number Hewlett-Packard PageWriter XLi ~ M1700A K951978 with M1791A Hewlett-Packard PageWriter 200i M1770A K935772 The interpretative cardiographic functions of the PageWriter 200i M… | 1996 |
| * | K935772 | HP M177XA CardiographsSummary page 2…listed below. Manufacturer Predicate Device = Model 510(k) Number Hewlett-Packard PageWriter XLi ~ M1700A K951978 with M1791A Hewlett-Packard PageWriter 200i M1770A K935772 The interpretative cardiographic functions of the PageWriter 200i Model M1770A with ACI-TIPI Model M1791A are identical to the p… | 1994 |
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 |
|---|---|---|---|
| K982025 | Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/Defibrillator | 1998 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K982025 (Hewlett-Packard Co., 1998) has gone furthest, with 0 descendants of its own.
What is it indicated for?
The PageWriter 200i Model M1770A is intended to provide acquisition, digitization and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG Data, The PageWriter 200i Model M1770A also displays ECG waveforms and records patient information entered through the alphanumeric keyboard. Additionally, it measures and provides interpretation. The PageWriter 200i Model M1770A interpreted ECG with measurements and diagnostic statements is…
Read the full statement (113 words)
The PageWriter 200i Model M1770A is intended to provide acquisition, digitization and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG Data, The PageWriter 200i Model M1770A also displays ECG waveforms and records patient information entered through the alphanumeric keyboard. Additionally, it measures and provides interpretation. The PageWriter 200i Model M1770A interpreted ECG with measurements and diagnostic statements is offered to the physician on an advisory basis only, and the physician is asked to overread and validate (or change) the ECG interpretation.
In addition, the PageWriter 200i Model M1770A with ACI-TIPI Model M1791A is intended to provide the cardiologist with an additional tool to aid in assessment of acute cardiac ischemia.
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/K981265 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981265: Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time Insensitive Predictive Instrumena.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981265
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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