510(k) · Cleared
ClearedCOR12+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare GmbH · DSH Recorder, Magnetic Tape, Medical
Cleared on Jun 10, 2009 as substantially equivalent to K050896 (Mortara Instrument, Inc., 2005) and 2 other predicates after a 20-day review. Its family tree reaches back 4 generations to 2000. 1 of the 17 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Jun 10, 2009
- Review
- 20 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002074 (2000). 10 ancestors in all, the oldest K911097 (1991). 6 later devices descend from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 3 generations backK070614 CorscreenViasys Healthcare GmbH · 2007
- 2 generations backK080734 Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008
- 1 generation backK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008
- This deviceK091505 COR12+Viasys Healthcare GmbH · 2009
- Descendant · cites it directly · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- Descendant · 2 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 ownK183567 Vyntus/SentrySuite Product LineVyaire Medical · 2019
- Descendant · 3 generations on · 0 of its ownK190853 Vyntus BODYVyaire Medical, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK183369 COR12 EcgCorscience GmbH & Co. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Linecites it directly · 2015
Most influential descendants
Showing 5 of 6 · See all- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · cites it directly5descendants
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 2 generations on1descendant
- K183567Vyntus/SentrySuite Product LineVyaire Medical · 2019 · 2 generations on0descendants
- K190853Vyntus BODYVyaire Medical, Inc. · 2019 · 3 generations on0descendants
- K183369COR12 EcgCorscience GmbH & Co. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −3 | K070614 | Corscreen | Viasys Healthcare GmbH | 2007 | — |
| −2 | K080734 | Flowscreen, Flowscreen/Corscreen, Flowscreen CT | Viasys Healthcare GmbH | 2008 | — |
| −1 | K082539 | Masterscope, Masterscope Ecg, Masterscope CT | Cardinal Health Germany 234 GmbH | 2008 | — |
| 0 (this device) | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| +1 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +2 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
| +2 | K183567 | Vyntus/SentrySuite Product Line | Vyaire Medical | 2019 | — |
| +3 | K190853 | Vyntus BODY | Vyaire Medical, Inc. | 2019 | — |
| +2 | K183369 | COR12 Ecg | Corscience GmbH & Co. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K050896 | H12+ Holter RecorderSummary page 2…rt 870 Code DSH 5.8 Reason for Premarket Notification New Device 5.9 Legally predicate marketed device 1. H12+ Holter Recorder K050896 Code DSH 2. Cardiette Microtel ECG K082124 Code DPS 3. MasterScope ECG K082539… | 2005 |
| * | K082124 | Carditte MicrotelSummary page 2…ion New Device 5.9 Legally predicate marketed device 1. H12+ Holter Recorder K050896 Code DSH 2. Cardiette Microtel ECG K082124 Code DPS 3. MasterScope ECG K082539 Code BTY I DPS 5.10 Predicate Device Company… | 2009 |
| * | K082539 | Masterscope, Masterscope Ecg, Masterscope CTSummary page 2…ce 1. H12+ Holter Recorder K050896 Code DSH 2. Cardiette Microtel ECG K082124 Code DPS 3. MasterScope ECG K082539 Code BTY I DPS 5.10 Predicate Device Company 1. Mortara Instrument, INC. 2. Et Medical devices SpA… | 2008 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150810 | Vyntus / SentrySuite Product Line Class I | 2015 | 5 |
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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K150810 (Carefusion Germany 234 GmbH, 2015) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K050896.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Cor12+ Holter Recorder is intended to acquire, record and store ECG data of patients that have been connected to the Cor12+ recorder and are undergoing Holter monitoring. The Corl2+ acquires, digitizes and stores data to be analyzed on a computer with special software.
The Cor12+ 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 24 hours.
The Corl2+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091505 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091505: COR12+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091505
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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