510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151776Substantially Equivalent

Central Venous Pressure System

Mespere Lifesciences Inc., Waterloo, CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151776 is the FDA 510(k) clearance record for Central Venous Pressure System, a class II device, cleared for Mespere Lifesciences, Inc. on under FDA product code PFA (Non-Invasive Central Venous Manometer). FDA's definition for product code PFA reads: "Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology". FDA records list 3 510(k) clearances for Mespere Lifesciences, Inc., from to . As of , FDA records show no recalls naming K151776.

Clearance record

Decision date
Received
(42 days to decision)
Product code
PFA Non-Invasive Central Venous Manometer
Regulation
21 CFR 870.1140
Device class
Class II
Review panel
Cardiovascular
Applicant
Mespere Lifesciences, Inc. 180 Frobisher Dr., Unit 1c, Waterloo, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFA

Trailing 12 months

FDA records hold no clearances under product code PFA in the trailing twelve months.

FDA records show no clearances under product code PFA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260