Atlas FDA

HGY

27 FDA 510(k) clearances · Product code

84 daysmedian time to decision
207 days90th percentile
27clearances measured

FDA profile

Official device name
Pump, Breast, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 884.5150
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2007: 2 · 2011: 6 · 2012: 6 · 2013: 12 · 2014: 7 · 2015: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (K101538)Philips Electronics UK Limited2010-11-05
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (K032845)The First Years, Inc.2004-04-05
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (K013226)Evenflo Company, Inc.2001-12-20
AMEDA HYGIENIKIT (K011519)Hollister, Inc.2001-08-15
WHITE RIVER MINI MANUAL BREAST PUMP (K971231)White River Concepts1997-05-19
EVERT-IT (K962828)Genesis Industries, Inc.1997-02-10
MEDELA'S FOOT PUMP (K952034)Medela, Inc.1995-09-12
NIPLETTE (K952035)Avent America, Inc.1995-07-28
WHITE RIVER MANUAL BREAST PUMP (K925738)White River (Tm)1994-05-04
MOTHERS TOUCH ONE HAND BREAST PUMP (K912355)Hollister, Inc.1993-12-10
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (K902552)Gerber Products Co.1990-09-26
CRYSTAL MANUAL BREAST PUMP (K850242)Crystal Medical Products, Inc.1985-02-25
SUPPLEMENTAL FEEDING SYSTEM (K844297)Medela, Inc.1985-02-25
THE BIBICURE SYS BREAST TONER (K843544)Les Entreprises Bibi, Inc.1985-01-25
RODY BREAST PUMP (K840874)Kean-Rody Manufacturer1984-07-23
INFA COMPLETE BREAST PUMP & MILK STORAG (K840325)Monterey Laboratories, Inc.1984-03-05
NEW MOTHER'S WAY-BREAST PUMP (K834399)Huntleigh Technology, Inc.1984-01-17
GENTLE FLOW BREAST PUMP (K833835)Eklund & Co.1983-11-28
BASIC BREAST PUMP (K831929)Terayco Intl., Ltd.1983-09-29
GERBER PRECISION CARE BREAST PUMP (K832597)Gerber Products Co.1983-09-12
MEDELA NAMUAL BREAST PUMP (K823840)Medela, Inc.1983-01-24
AXIPUMP MANUAL BREAST PUMP (K823461)D.J. Colgate Medical, Ltd.1983-01-18
AMEDA HAND BREAST PUMP (K823591)Burditt & Calkins-Siemens-Elema1982-12-28
LACT-ASSIST BREAST PUMP (K822403)Lact-Assist, Inc.1982-09-21
KANESON/COMFORT PLUS MANUAL BREAST PUMP (K813247)Marshall Electronics, Inc.1981-12-03
BREAST PUMP (K810100)American Hospital Supply Corp.1981-02-12
BREAST CARE KIT (K760911)American Hospital Supply Corp.1976-11-11

Track HGY automatically

Every clearance here is in the API, with alerts when new ones post.