510(k) · Cleared
Recalled · Class II · 2020H12+ Holter Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Aug 24, 2005 as substantially equivalent to K911097 (Mortara Instrument, Inc., 1991) after a 138-day review. Its family tree reaches back 1 generation to 1991. 1 of the 12 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once.
- Decided
- Aug 24, 2005
- Review
- 138 days
- Class
- Class II
- Product code
- DSH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911097 (1991). 10 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK911097 PR4Mortara Instrument, Inc. · 1991
- This deviceK050896 H12+ Holter RecorderMortara Instrument, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK091505 COR12+Viasys Healthcare GmbH · 2009
- Descendant · 2 generations on · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Line2 generations on · 2015
Most influential descendants
Showing 5 of 10 · See all- K091505COR12+Viasys Healthcare GmbH · 2009 · cites it directly6descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 2 generations on5descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · cites it directly2descendants
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 3 generations on1descendant
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| 0 (this device) | K050896 | H12+ Holter Recorder | Mortara Instrument, Inc. | 2005 | — |
| +1 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| +2 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +1 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +3 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
| +2 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K911097 | PR4Summary page 1…to which S. E. is claimed The H1 2+ Holler Recorder is a modification of a legally marketed Mortara predicate device. Mortara PR4 Helter analysis Recorder (K91 10977) Note: For commercial reasons, Mortara changed the proprietary name from PR 4 to H-12 in 1995 and has continued… | 1991 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2020 | Class II | Z-1812-2020 | Device Design | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The H 12+ Holter recorder is intended to acquire, record and store ECG data of patients thathave been connected to the Mortara H 12+ recorder and are undergoing Holter monitoring. The Hi 2+ acquires, digitizes and stores data to be analyzed by the H-Scribe Hoiter system.
The H12+ is indicated for use:
* in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 48 hours.
* The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Hotter analysis system (K004017). ECG data prerecorded by the HI12+ is acquired and analyzed by the H-Scribe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050896: H12+ Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050896
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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