510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930238Substantially Equivalent

Breast Leakage Inhibitor System: Breast Shields

Prolac, Inc., Skaneateles NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930238 is the FDA 510(k) clearance record for BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS, a class I device, cleared for Prolac, Inc. on under FDA product code HFS (Shield, Nipple). FDA records list one 510(k) clearance for Prolac, Inc. As of , FDA records show no recalls naming K930238.

Clearance record

Decision date
Received
(209 days to decision)
Product code
HFS Shield, Nipple
Regulation
21 CFR 880.5630
Device class
Class I
Review panel
General Hospital
Applicant
Prolac, Inc. 3 Lake View Cir., Skaneateles NY
510(k) summary
Statement
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