510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935944Substantially Equivalent

Proscopes and Adscopes

American Diagnostic Corp., West Babylon NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935944 is the FDA 510(k) clearance record for PROSCOPES AND ADSCOPES, a class I device, cleared for American Diagnostic Corp. on under FDA product code LDE (Stethoscope, Manual). FDA records list 39 510(k) clearances for American Diagnostic Corp., from to . As of , FDA records show no recalls naming K935944.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LDE Stethoscope, Manual
Regulation
21 CFR 870.1875
Device class
Class I
Review panel
Cardiovascular
Applicant
American Diagnostic Corp. 93 Otis St., West Babylon NY
510(k) summary
Statement
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