510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854146Substantially Equivalent

Surgical & Dental Instrument

Baort, Inc., South Orange NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854146 is the FDA 510(k) clearance record for SURGICAL & DENTAL INSTRUMENT, a class I device, cleared for Baort, Inc. on under FDA product code GEN (Forceps, General & Plastic Surgery). FDA records list one 510(k) clearance for Baort, Inc. As of , FDA records show no recalls naming K854146.

Clearance record

Decision date
Received
(33 days to decision)
Product code
GEN Forceps, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Baort, Inc. P.O. Box 682, South Orange NJ
Third party review
No

Clearances, product code GEN

Trailing 12 months

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

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