510(k) · Cleared
ClearedTonoport V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Par Medizintechnik GmbH · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 9, 2001 as substantially equivalent to K964235 (Industrielle Entwicklung Medizintechnik Und Vertri, 1999) after an 88-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 9, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K855127 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
- 1 generation backK964235 Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlIndustrielle Entwicklung Medizintechnik Und Vertri · 1999
- This deviceK012647 Tonoport VPar Medizintechnik GmbH · 2001
- Descendant · cites it directly · 0 of its ownK170966 Tonoport VIPar Medizintechnik GmbH & Co. KG · 2017
- Descendant · cites it directly · 0 of its ownK021029 ABP-2000 G-3Biotrac, Inc. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202 | Spacelabs, Inc. | 1986 | — |
| −1 | K964235 | Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control | Industrielle Entwicklung Medizintechnik Und Vertri | 1999 | — |
| 0 (this device) | K012647 | Tonoport V | Par Medizintechnik GmbH | 2001 | — |
| +1 | K170966 | Tonoport VI | Par Medizintechnik GmbH & Co. KG | 2017 | — |
| +1 | K021029 | ABP-2000 G-3 | Biotrac, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2017 | 1 | 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.
Planning a device in DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K964235 | Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlSummary page 1…: +49302138542 Tonoport V NIBP Holter System 21 CFR 870.1130 Non-Invasive Blood-Pressure Measurement System DXN Predicate Device: Device Description: Intended Use: K964235 Device Name: ABPM Mobil-o-Graph Blood Pressure Monitor, Model ABP Control The Tonoport V is a compact, lightweight, patient-born… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K170966 (Par Medizintechnik GmbH & Co. KG, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K964235.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Tonoport V is a compact, lightweight, patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method. The cuff is borne on the upper arm and an electrical pump inside the device generates the pressure in the cuff. The Tonoport V is powered from two AA size batteries (alkaline or rechargeable NiMH batteries). For periods of up to 30 hours it records the patient’s blood pressure at predefined intervals and save the results. In…
Read the full statement (294 words)
The Tonoport V is a compact, lightweight, patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method. The cuff is borne on the upper arm and an electrical pump inside the device generates the pressure in the cuff. The Tonoport V is powered from two AA size batteries (alkaline or rechargeable NiMH batteries).
For periods of up to 30 hours it records the patient’s blood pressure at predefined intervals and save the results.
In order to assess the measurements, the stored data can be transmitted via a RS-232 interface to a 9-needle dot-matrix printer with serial interface (EPSON LX-300+) or to another medical device for further evaluation or archiving purposes.
Tonoport V is intended to be used for measuring the systolic, diastolic, mean blood pressure and the heart rate of human beings for periods up to 30 hours. The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 cm to 42 cm.
Tonoport V is a prescription device in health care medicine. It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressure measuring under his observation. Medically trained staff like a doctor or nurse, etc should do this judgment as well as the accommodation of the patients and the preparation and application of the Tonoport. The patient does not operate with the Tonoport V by himself. A measurement with Tonoport V is combined with other measurements and medical examinations at the patient, so that a diagnosis about the patient’s health condition depends not alone from the measurement of the Tonoport V.
Tonoport V is not intended to be used in home care medicine or in intensive care medicine or for alarming of life-threatening conditions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012647 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012647: Tonoport V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012647
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026