510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811364Substantially Equivalent

Axicare Breast Shell

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

K811364 is the FDA 510(k) clearance record for AXICARE BREAST SHELL, a class I device, cleared for Neonatal Corp. on under FDA product code HFS (Shield, Nipple). FDA records list 3 510(k) clearances for Neonatal Corp., from to . As of , FDA records show no recalls naming K811364.

Clearance record

Decision date
Received
(81 days to decision)
Product code
HFS Shield, Nipple
Regulation
21 CFR 880.5630
Device class
Class I
Review panel
General Hospital
Applicant
Neonatal Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HFS

Trailing 12 months

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

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