510(k) · Cleared
ClearedCarditte Microtel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Et Medical Devices Spa · DPS Electrocardiograph
Cleared on Feb 19, 2009 as substantially equivalent to K051534 (Et Medical Devices Spa, 2005) after a 206-day review. Its family tree reaches back 2 generations to 2000. 1 of the 15 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Feb 19, 2009
- Review
- 206 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002074 (2000). 12 later devices descend from it, 3 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 1 generation backK051534 Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa · 2005
- This deviceK082124 Carditte MicrotelEt Medical Devices Spa · 2009
- 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 · 3 of its ownK150289 Cardioline HD+Cardioline S.P.A · 2015
- 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 ownK223670 MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · 2023
Showing 5 of 12 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 12 · See all- K091505COR12+Viasys Healthcare GmbH · 2009 · cites it directly6descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 2 generations on5descendants
- K150289Cardioline HD+Cardioline S.P.A · 2015 · cites it directly3descendants
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 3 generations on1descendant
- K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −1 | K051534 | Cardioline AR 600, AR 1200, AR 2100 | Et Medical Devices Spa | 2005 | — |
| 0 (this device) | K082124 | Carditte Microtel | Et Medical Devices Spa | 2009 | — |
| +1 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
| +2 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +1 | K150289 | Cardioline HD+ | Cardioline S.P.A | 2015 | — |
| +3 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
| +2 | K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2023 | 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K051534 | Cardioline AR 600, AR 1200, AR 2100Summary page 2…is: Manufacturer Applicant Name Predicate Device 510(k) Number Name et medical devices SpA et medical devices SpA CARDIOLINE K051534 AR 600, AR 1200 and AR 2100 Th… | 2005 |
What descends from it? (12)
See all 123 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 · 2 generations on · ◆ 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 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091505 (Viasys Healthcare GmbH, 2009) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K051534.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboait The electrical hear activity is detected by means of two or more eiectrocardio?!h eaectrnde- ard the devicecan acquire and transmit an ECG trace in analogue (via sound coupling).or'digitatformat (USB port or via the wireless Bluetooth channel) to a remote PC. The equipments are intended for use in routine ecg recording in physician practice and/or hospital. Intended use for…
Read the full statement (206 words)
cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboait
The electrical hear activity is detected by means of two or more eiectrocardio?!h eaectrnde- ard the
devicecan acquire and transmit an ECG trace in analogue (via sound coupling).or'digitatformat (USB port or
via the wireless Bluetooth channel) to a remote PC.
The equipments are intended for use in routine ecg recording in physician practice and/or hospital.
Intended use for non interpretive applications covers the full range of patient population with no limitations
with respect to age, sex and race of the patient.
The equipment is intended to be used by trained medical personnel or physicians.
cardiette microtel does not include ecg interpretation tools and/or analysis programs. The device is
intended to transmit ECG waveforms to a PC. Analysis program on a PC is a separate product not marketed
with the Cardiette Microtel.
The hardware and the software of the equipment, except for the paper recorder routines and interpretation
program, are the same of the predicated device.
Indication for: use of cardiette microtel has not been changed, except for the ecg interpretation
program not present on this device, with respect to the predicate device CARDIOLINE AR600,
AR1200, AR2100 (ref. K051534 CARDIOLINE AR600, AR1200, AR2100).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082124: Carditte Microtel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082124
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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