510(k) · Cleared
ClearedInfinity Cnap Smartpod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 18, 2011 as substantially equivalent to K082599 (Cnsystem Medizintechnik AG, 2008) after a 135-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 18, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962603 (1997). 14 ancestors in all, the oldest K880572 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 2 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 1 generation backK082599 Non-Invasive Continuous Blood Pressure Monitoring System Cnap…Cnsystem Medizintechnik AG · 2008
- This deviceK102968 Infinity Cnap SmartpodDraeger Medical Systems, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK131085 Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK151776 Central Venous Pressure SystemMespere Lifesciences, Inc. · 2015
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 |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −2 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −1 | K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I… | Cnsystem Medizintechnik AG | 2008 | — |
| 0 (this device) | K102968 | Infinity Cnap Smartpod | Draeger Medical Systems, Inc. | 2011 | — |
| +1 | K131085 | Central Venous Pressure System - Mespere Venus 1000 | Mespere Lifesciences, Inc. | 2013 | — |
| +2 | K151776 | Central Venous Pressure System | Mespere Lifesciences, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATSummary page 1…11 4. Legally Marketed Equivalent (Predicate) Device Names: Substantial equivalence is claimed to the CNSystems CNAP Monitor 5O0i under submission # K082599 DRAEGER MEDICAL SYSTEMS, INC. 6 Tech Drive Andover, MA 01810-2434 Tel: 215-660-2626 Fax: 215-721-5424 Cell: 267-885-9989 ===… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131085 | Central Venous Pressure System - Mespere Venus 1000 | 2013 | 1 |
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 14 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K131085 (Mespere Lifesciences, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K082599.
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. 2011, 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 Infinity CNAP SmartPod is indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults by medical professionals. The Infinity CNAP SmartPod is intended for use with the Infinity Modular patient monitors of the Delta series (Delta, Delta XL, Kappa, 507000, 508000, SC9000XL). Derived arterial values and pressure waveforms are displayed when a pod is connected to one of the previously identified patient monitors. The…
Read the full statement (190 words)
The Infinity CNAP SmartPod is indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults by medical professionals. The Infinity CNAP SmartPod is intended for use with the Infinity Modular patient monitors of the Delta series (Delta, Delta XL, Kappa, 507000, 508000, SC9000XL). Derived arterial values and pressure waveforms are displayed when a pod is connected to one of the previously identified patient monitors.
The Infinity ONAP SmartPod supports the following parameters:
Continuous and oscillometric blood pressure
Pulse rate
CNAP-S (systolic pressure)
CNAP-D (diastolic pressure)
CNAP-M (mean pressure)
The Infinity ONAP Smartpod performance may be affected in situations where the flow of blood to the finger is severely inhibited or in the presence of pathologically increased stiffness of the finger arteries. Included as examples:
* Cases of severe shock or hypothermia
* Severe arteriosclerosis of the upper extremities
* Primary or secondary Raynaud's syndrome and related diseases
* Endarteritis obliterans
* Collagenosis affecting peripheral arteries
The Infinity CNAP SmartPod is not intended for use on patients with vascular implants at the site of measurement.
The Infinity CNAP SmartPod is not compatible for use in a MRI magnetic field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102968 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102968: Infinity Cnap Smartpod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102968
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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