510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823226Substantially Equivalent

Sn-100 Doctor's Round

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

K823226 is the FDA 510(k) clearance record for SN-100 DOCTOR'S ROUND, a class I device, cleared for Kells Medical, Inc. on under FDA product code ETF (Unit, Examining/Treatment, Ent). FDA records list 12 510(k) clearances for Kells Medical, Inc., from to . As of , FDA records show no recalls naming K823226.

Clearance record

Decision date
Received
(24 days to decision)
Product code
ETF Unit, Examining/Treatment, Ent
Regulation
21 CFR 874.5300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Kells Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ETF

Trailing 12 months

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

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