510(k) · Cleared
ClearedCentral Venous Pressure System - Mespere Venus 1000
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 22, 2013 as substantially equivalent to K014054 (Edwards Lifesciences, LLC, 2002) and 2 other predicates after a 126-day review. Its family tree reaches back 8 generations to 1997. 1 later device descends from it.
- Decided
- Aug 22, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- PFA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K962603 (1997). 33 ancestors in all, the oldest K863784 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 3 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 2 generations backK082599 Non-Invasive Continuous Blood Pressure Monitoring System Cnap…Cnsystem Medizintechnik AG · 2008
- 1 generation backK102968 Infinity Cnap SmartpodDraeger Medical Systems, Inc. · 2011
- This deviceK131085 Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK151776 Central Venous Pressure SystemMespere Lifesciences, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151776Central Venous Pressure SystemMespere Lifesciences, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −3 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −2 | K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I… | Cnsystem Medizintechnik AG | 2008 | — |
| −1 | K102968 | Infinity Cnap Smartpod | Draeger Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K131085 | Central Venous Pressure System - Mespere Venus 1000 | Mespere Lifesciences, Inc. | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K014054 | Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon MaterialSummary page 1…Common name: CVP System Classification 870.1140 (Product code PFA) name: Classification: Class 11 Medical Device Predicate Device: K014054 EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL… | 2002 |
| * | K120773 | Nellcor Bedside SPO2 Patient Monitoring SystemSummary page 1…CATHETER WITH OLIGON MATERIAL Product code: DQO Regulation number: 870.1200 K 120773 Nellcor Bedside SP02 Patient Monitoring System Product code: DQA… | 2012 |
| * | K102968 | Infinity Cnap SmartpodSummary page 1…Nellcor Bedside SP02 Patient Monitoring System Product code: DQA Regulation Number: 870.2700 K 102968 Draeger Infinity CNAP SmartPod Product Code: DXN Regulati… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151776 | Central Venous Pressure System | 2015 | 0 |
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 16 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 33 ancestors have a recall of any class.
- Of its descendants, K151776 (Mespere Lifesciences, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K014054.
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. 2013, 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?
Mespere Venus 1000 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/K131085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131085: Central Venous Pressure System - Mespere Venus 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131085
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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