510(k) · Cleared
ClearedCentral Venous Pressure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mespere Lifesciences, Inc. · PFA Non-Invasive Central Venous Manometer
Cleared on Aug 12, 2015 as substantially equivalent to K131085 (Mespere Lifesciences, Inc., 2013) after a 42-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Aug 12, 2015
- Review
- 42 days
- Class
- Class II
- Product code
- PFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962603 (1997). 34 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK082599 Non-Invasive Continuous Blood Pressure Monitoring System Cnap…Cnsystem Medizintechnik AG · 2008
- 2 generations backK102968 Infinity Cnap SmartpodDraeger Medical Systems, Inc. · 2011
- 1 generation backK131085 Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc. · 2013
- This deviceK151776 Central Venous Pressure SystemMespere Lifesciences, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 3 generations backK082599 Non-Invasive Continuous Blood Pressure Monitoring System Cnap…Cnsystem Medizintechnik AG · 2008
- 2 generations backK102968 Infinity Cnap SmartpodDraeger Medical Systems, Inc. · 2011
- 1 generation backK131085 Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc. · 2013
- This deviceK151776 Central Venous Pressure SystemMespere Lifesciences, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −3 | K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I… | Cnsystem Medizintechnik AG | 2008 | — |
| −2 | K102968 | Infinity Cnap Smartpod | Draeger Medical Systems, Inc. | 2011 | — |
| −1 | K131085 | Central Venous Pressure System - Mespere Venus 1000 | Mespere Lifesciences, Inc. | 2013 | — |
| 0 (this device) | K151776 | Central Venous Pressure System | Mespere Lifesciences, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 PFA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K131085 | Central Venous Pressure System - Mespere Venus 1000Summary page 4…2000 Common name: CVP System Classification 870.1140 (Product code PFA) name: Classification: Class II Medical Device Predicate Device: K131085 Central Venous Pressure System – Mespere Venus 1000 Product code: PFA… | 2013 |
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 18 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 34 ancestors have a recall of any class.
How does its category compare?
All PFA devicesPFA Non-Invasive Central Venous Manometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PFA
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PFA
Too few PFA 510(k)s in any year since 2007 to give a median.
Recalls per year · PFA
No recall names PFA since 2007.
Adverse event reports per year · PFA
3in 2025
MAUDE reports naming product code PFA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 28 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CVP-VENUS-2000 is intended to be used by healthcare professionals for assessment of central venous blood pressure (CVP) of adult individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151776: Central Venous Pressure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151776
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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