510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K813510Substantially Equivalent

Cardiosonic Acoustic Amplifier

Srs Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813510 is the FDA 510(k) clearance record for CARDIOSONIC ACOUSTIC AMPLIFIER, a class I device, cleared for Srs Co. on under FDA product code LDE (Stethoscope, Manual). FDA records list 2 510(k) clearances for Srs Co., from to . As of , FDA records show no recalls naming K813510.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LDE Stethoscope, Manual
Regulation
21 CFR 870.1875
Device class
Class I
Review panel
Cardiovascular
Applicant
Srs Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LDE

Trailing 12 months

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

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