510(k) · Cleared
ClearedTonoport VI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Par Medizintechnik GmbH & Co. KG · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 14, 2017 as substantially equivalent to K012647 (Par Medizintechnik GmbH, 2001) after a 75-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jun 14, 2017
- Review
- 75 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K855127 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
- 2 generations backK964235 Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlIndustrielle Entwicklung Medizintechnik Und Vertri · 1999
- 1 generation backK012647 Tonoport VPar Medizintechnik GmbH · 2001
- This deviceK170966 Tonoport VIPar Medizintechnik GmbH & Co. KG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202 | Spacelabs, Inc. | 1986 | — |
| −2 | K964235 | Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control | Industrielle Entwicklung Medizintechnik Und Vertri | 1999 | — |
| −1 | K012647 | Tonoport V | Par Medizintechnik GmbH | 2001 | — |
| 0 (this device) | K170966 | Tonoport VI | Par Medizintechnik GmbH & Co. KG | 2017 | — |
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 |
|---|---|---|---|
| * | K012647 | Tonoport VSummary page 4…DXN, Class II) Legally marked Device name: TONOPORT V device: 510(k) number: K012647 5.1 Device Description Table 4: Device description Device functions: The TONOPORT VI measures the blood pressure non-in… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 4 companies; a new generation was cleared every 12.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K012647.
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. 2017, this device’s year, is highlighted.
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 VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined…
Read the full statement (276 words)
The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software.
TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings.
The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm.
TONOPORT VI is a prescription device in health care medicine and is intended for use following consultation and instruction by a physician (family doctor, specialist or hospital). It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressure measurement. Preparation and application of the TONOPORT VI is done by medically trained staff. The patient does not operate with the TONOPORT VI by himself. TONOPORT VI is not intended to be used in intensive care medicine or for alarming of life-threatening conditions.
A measurement with TONOPORT VI can be combined with other measurements and medical examinations at the patient that a diagnosis about the patient’s health condition depends not alone from the measurement of the TONOPORT VI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170966: Tonoport VI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170966
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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