510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K941112Substantially Equivalent

Single Handed Breast Pump

Macneil Baby Care, Ltd., Downers Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941112 is the FDA 510(k) clearance record for SINGLE HANDED BREAST PUMP, a class II device, cleared for Macneil Baby Care , Ltd. on under FDA product code HGX (Pump, Breast, Powered). FDA records list one 510(k) clearance for Macneil Baby Care , Ltd. As of , FDA records show no recalls naming K941112.

Clearance record

Decision date
Received
(329 days to decision)
Product code
HGX Pump, Breast, Powered
Regulation
21 CFR 884.5160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Macneil Baby Care , Ltd. 5161 Thatcher Rd., Downers Grove IL
510(k) summary
Statement
Third party review
No

Clearances, product code HGX

Trailing 12 months
37 clearances under product code HGX in the twelve months to October 2026, April 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code HGX, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20262
April 20268
May 20263
June 20268
July 20262
August 20262
September 20263
October 20260