510(k) Report

510(k) · Cleared

Cleared

Pagewriter Xli M1700A & Pagewriter XL M1701A

K895520510(k) TraditionalCleared Jul 17, 1990308-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 Jul 17, 1990 after a 308-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 58 later devices descend from it.

Decided
Jul 17, 1990
Review
308 days
Product code
LOS
Recalls
None
Predicates
0

58 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared2017: 4 descendants cleared2002: 1 descendant cleared2013: 3 descendants cleared2005: 3 descendants cleared2008: 4 descendants cleared2003: 2 descendants cleared1998: 1 descendant cleared2007: 3 descendants cleared2006: 1 descendant cleared2009: 5 descendants cleared2010: 2 descendants cleared2012: 2 descendants cleared2020: 1 descendant cleared2022: 5 descendants cleared2021: 3 descendants cleared2015: 3 descendants cleared2011: 2 descendants cleared2016: 3 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2023: 3 descendants cleared1990200020102020
  1. This deviceK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
  2. Descendant · cites it directly · 47 of its ownK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 27 of its ownK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
  4. Descendant · 3 generations on · 12 of its ownK050074 12-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005
  5. Descendant · 3 generations on · 11 of its ownK060167 Atria 3100, Atria 6100Cardiac Science Corporation · 2006
  6. Descendant · 4 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

1996: 21998: 12002: 12003: 22005: 32006: 12007: 32008: 42009: 52010: 22011: 22012: 22013: 32014: 12015: 32016: 32017: 42018: 12020: 12021: 32022: 52023: 32024: 22026: 1
1996high 5 (2009) · low 0 (1997)2026

Most influential descendants

Showing 5 of 58 · See all
  • K020708Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · cites it directly47descendants
  • K031422Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…Philips Medical Systems · 2003 · 2 generations on27descendants
  • K05007412-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005 · 3 generations on12descendants
  • K060167Atria 3100, Atria 6100Cardiac Science Corporation · 2006 · 3 generations on11descendants
  • K160876PC ECGEdan Instruments, Inc. · 2017 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895520Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co.1990—
+1K020708Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc.20022
+2K031422Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models…Philips Medical Systems2003—
+3K05007412-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc.2005—
+3K060167Atria 3100, Atria 6100Cardiac Science Corporation2006—
+4K160876PC ECGEdan Instruments, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199810
200210
200320
200530
200610
200730
200840
200950
201020
201120
201220
201330
201410
201530
201630
201740
201810
202010
202130
202250
202330
202420
202610
FIG. 1 — Lineage of K895520, 1990–2026Source: 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.

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
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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? (58)

See all 58

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020708Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc.200247
K954980Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co.19968
K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170
K961272Nihon Kohden Ecg-9320A Cardiofax and AccessoriesNihon Kohden America, Inc.19960

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, K020708 (Philips Medical Systems, Inc., 2002) has gone furthest, with 47 descendants of its own.
Cite this page

510(k) Report. “K895520: Pagewriter Xli M1700A & Pagewriter XL M1701A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895520

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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