510(k) · Cleared
ClearedEcg Fax Modem
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 26, 1995 after a 441-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- May 26, 1995
- Review
- 441 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK941282 Ecg Fax ModemHewlett-Packard Co. · 1995
- Descendant · cites it directly · 8 of its ownK954980 Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996
- Descendant · 2 generations on · 6 of its ownK032200 Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003
- Descendant · 2 generations on · 5 of its ownK072353 Portable EcscopeDyansys Corp · 2007
- Descendant · 2 generations on · 2 of its ownK080036 Portable Ecscope 12IDyansys, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK082013 Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K954980Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996 · cites it directly8descendants
- K032200Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003 · 2 generations on6descendants
- K072353Portable EcscopeDyansys Corp · 2007 · 2 generations on5descendants
- K080036Portable Ecscope 12IDyansys, Inc. · 2008 · 2 generations on2descendants
- K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941282 | Ecg Fax Modem | Hewlett-Packard Co. | 1995 | — |
| +1 | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | 1996 | — |
| +2 | K032200 | Elan Digital 12 Channel Electrocardiograph | Remco Italia S.P.A. | 2003 | — |
| +2 | K072353 | Portable Ecscope | Dyansys Corp | 2007 | — |
| +2 | K080036 | Portable Ecscope 12I | Dyansys, Inc. | 2008 | — |
| +3 | K082013 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 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? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | 1996 | 8 |
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, K954980 (Hewlett-Packard Co., 1996) has gone furthest, with 8 descendants of its own.
https://510kreport.com/device/K941282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941282: Ecg Fax Modem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941282
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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