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
K760360Substantially Equivalent

Shirt, Mitten Cuff Infant

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

K760360 is the FDA 510(k) clearance record for SHIRT, MITTEN CUFF INFANT, a class I device, cleared for Precept, Inc. on under FDA product code FME (Gown, Examination). FDA records list 5 510(k) clearances for Precept, Inc., from to . As of , FDA records show no recalls naming K760360.

Clearance record

Decision date
Received
(79 days to decision)
Product code
FME Gown, Examination
Regulation
21 CFR 880.6265
Device class
Class I
Review panel
General Hospital
Applicant
Precept, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FME

Trailing 12 months

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

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