510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011519Substantially Equivalent

Ameda Hygienikit

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

K011519 is the FDA 510(k) clearance record for AMEDA HYGIENIKIT, a class I device, cleared for Hollister, Inc. on under FDA product code HGY (Pump, Breast, Non-Powered). FDA records list 85 510(k) clearances for Hollister, Inc., from to . As of , FDA records show one recall naming K011519.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HGY Pump, Breast, Non-Powered
Regulation
21 CFR 884.5150
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Hollister, Inc. 2000 Hollister Dr., Libertyville IL
510(k) summary
Summary
Third party review
No

Clearances, product code HGY

Trailing 12 months

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

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