510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K131285Substantially Equivalent

Sonosentry

Isonea, Ltd., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131285 is the FDA 510(k) clearance record for SONOSENTRY, a class II device, cleared for Isonea, Ltd. on under FDA product code PHZ (Abnormal Breath Sound Device). FDA's definition for product code PHZ reads: "The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling". FDA records list one 510(k) clearance for Isonea, Ltd. As of , FDA records show no recalls naming K131285.

Clearance record

Decision date
Received
(470 days to decision)
Product code
PHZ Abnormal Breath Sound Device
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Applicant
Isonea, Ltd. 6965 El Camino Real, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHZ

Trailing 12 months
2 clearances under product code PHZ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PHZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260