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
K223166Substantially Equivalent

Medaica M1 Telehealth Stethoscope

Medaica Inc, Henderson NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223166 is the FDA 510(k) clearance record for Medaica M1 Telehealth Stethoscope, a class II device, cleared for Medaica, Inc. on under FDA product code DQD (Stethoscope, Electronic). FDA records list one 510(k) clearance for Medaica, Inc. As of , FDA records show no recalls naming K223166.

Clearance record

Decision date
Received
(104 days to decision)
Product code
DQD Stethoscope, Electronic
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Medaica, Inc. 170 S. Green Valley Pkwy. Suite 300, Henderson NV
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DQD

Trailing 12 months
6 clearances under product code DQD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DQD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20262
August 20260
September 20260
October 20260