510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830796Substantially Equivalent

The Bloom Stethoscope

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

K830796 is the FDA 510(k) clearance record for THE BLOOM STETHOSCOPE, a class I device, cleared for Stethophonics, Inc. on under FDA product code LDE (Stethoscope, Manual). FDA records list one 510(k) clearance for Stethophonics, Inc. As of , FDA records show no recalls naming K830796.

Clearance record

Decision date
Received
(127 days to decision)
Product code
LDE Stethoscope, Manual
Regulation
21 CFR 870.1875
Device class
Class I
Review panel
Cardiovascular
Applicant
Stethophonics, Inc. 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