510(k) · Cleared
ClearedPR4
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 7, 1991 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 21 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Aug 7, 1991
- Review
- 148 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- This deviceK911097 PR4Mortara Instrument, Inc. · 1991
- Descendant · cites it directly · 11 of its ownK021373 H12+Holter RecorderMortara Instrument, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK050896 H12+ Holter RecorderMortara Instrument, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK091505 COR12+Viasys Healthcare GmbH · 2009
- Descendant · 3 generations on · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK043010 Holter Recorder H3+Mortara Instrument, Inc. · 2005
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Line3 generations on · 2015
Most influential descendants
Showing 5 of 20 · See all- K021373H12+Holter RecorderMortara Instrument, Inc. · 2002 · cites it directly11descendants
- K050896H12+ Holter RecorderMortara Instrument, Inc. · 2005 · cites it directly10descendants
- K091505COR12+Viasys Healthcare GmbH · 2009 · 2 generations on6descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 3 generations on5descendants
- K043010Holter Recorder H3+Mortara Instrument, Inc. · 2005 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| +1 | K021373 | H12+Holter Recorder | Mortara Instrument, Inc. | 2002 | — |
| +1 | K050896 | H12+ Holter Recorder | Mortara Instrument, Inc. | 2005 | 1 |
| +2 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| +3 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +2 | K043010 | Holter Recorder H3+ | Mortara Instrument, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2026 | 2 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 202 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)
No FDA recall names this device.
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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021373 (Mortara Instrument, Inc., 2002) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K911097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K911097: PR4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911097
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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