510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191876Substantially Equivalent

PulmoScan

Cognita Labs LLC, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191876 is the FDA 510(k) clearance record for PulmoScan, a class II device, cleared for Cognita Labs, LLC on under FDA product code PNV (Impedance Measuring Device Utilizing Oscillation Techniques). FDA's definition for product code PNV reads: "This device measures respiratory impedance". FDA records list 2 510(k) clearances for Cognita Labs, LLC, from to . As of , FDA records show no recalls naming K191876.

Clearance record

Decision date
Received
(247 days to decision)
Product code
PNV Impedance Measuring Device Utilizing Oscillation Techniques
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Cognita Labs, LLC 700 N Main St. Suite C1, Santa Ana CA
510(k) summary
Statement
Third party review
No

Clearances, product code PNV

Trailing 12 months

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

FDA records show no clearances under product code PNV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PNV, 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