510(k) · Cleared
ClearedPagewriter 200, 200I Cardiograph & Interpretive Cardio
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 May 15, 1996 as substantially equivalent to K895520 (Hewlett-Packard Co., 1990) and 1 other predicate after a 197-day review. Its family tree reaches back 1 generation to 1990. 8 later devices descend from it.
- Decided
- May 15, 1996
- Review
- 197 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895520 (1990). 2 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- This deviceK954980 Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996
- Descendant · cites it directly · 6 of its ownK032200 Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003
- Descendant · cites it directly · 5 of its ownK072353 Portable EcscopeDyansys Corp · 2007
- Descendant · cites it directly · 2 of its ownK080036 Portable Ecscope 12IDyansys, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK082013 Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008
- Descendant · 2 generations on · 0 of its ownK091397 Ecscope 200Dyansys, Inc. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032200Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003 · cites it directly6descendants
- K072353Portable EcscopeDyansys Corp · 2007 · cites it directly5descendants
- K080036Portable Ecscope 12IDyansys, Inc. · 2008 · cites it directly2descendants
- K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008 · 2 generations on1descendant
- K091397Ecscope 200Dyansys, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| 0 (this device) | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | 1996 | — |
| +1 | K032200 | Elan Digital 12 Channel Electrocardiograph | Remco Italia S.P.A. | 2003 | — |
| +1 | K072353 | Portable Ecscope | Dyansys Corp | 2007 | — |
| +1 | K080036 | Portable Ecscope 12I | Dyansys, Inc. | 2008 | — |
| +2 | K082013 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | 2008 | — |
| +2 | K091397 | Ecscope 200 | Dyansys, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701ASummary page 2…with option A05 will: - Transmit via direct connect or fax modem using a Hewlett Packard digital communications protocol to PageWriter XLi cardiographs (Model M1700A, K#895520) and PageWriter 200 series cardiographs with A05 - Transmit to and receive from an automated HP EZG management system. - Transm… | 1990 |
| * | K941282 | Ecg Fax ModemSummary page 1…nt to the intended use of the PageWriter XLi with Direct Digital FAX (Model M1706B) currently marketed which received FDA's substantial equivalence determination under K#941282, i.e., it is intended to be used to transmit ECGs for management or physician review or copying and transmit to another device.… | 1995 |
| * | — | PageWriter 200i (Model M1770A) Named without a submission number | |
| * | — | PageWriter 200 (Model M1771A) Named without a submission number |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
What is it indicated for?
The PageWriter 200 series cardiographs with option #A05 transmit ECGs for management or physician review or copying. ECGs can be transmitted to another PageWriter cardiograph or to a general purpose fax device. Option #A05 also provides ECG storage capability in the cardiograph. The intended use of the PageWriter 200i and 200 with option #A05 is substantially equivalent to the intended use of the PageWriter XLi with Direct Digital FAX (Model M1706B)…
Read the full statement (198 words)
The PageWriter 200 series cardiographs with option #A05 transmit ECGs for management or physician review or copying. ECGs can be transmitted to another PageWriter cardiograph or to a general purpose fax device. Option #A05 also provides ECG storage capability in the cardiograph.
The intended use of the PageWriter 200i and 200 with option #A05 is substantially equivalent to the intended use of the PageWriter XLi with Direct Digital FAX (Model M1706B) currently marketed which received FDA's substantial equivalence determination under K#941282, i.e., it is intended to be used to transmit ECGs for management or physician review or copying and transmit to another device.
The PageWriter 200i and 200 with option #A05 is intended to be used in a hospital environment or in a physician's office. The cardiograph is used to acquire, digitize, record, and transmit conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data. The cardiograph also records patient data entered through the alphanumeric keyboard. Additionally, the PageWriter 200i cardiograph measures and provides ECG interpretation. The 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.
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/K954980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954980: Pagewriter 200, 200I Cardiograph & Interpretive Cardio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954980
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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