Easy Comfort Deluxe Manual Breast Pump, Model 1187

FDA 510(k) K032845 · The First Years, Inc.

Substantially Equivalent

510(k) numberK032845

Submission

Device name
Easy Comfort Deluxe Manual Breast Pump, Model 1187
Applicant
The First Years, Inc.
Avon, MA, US
Received
September 11, 2003
Decision date
April 5, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HGY – Pump, Breast, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 884.5150
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HGY

510(k)DeviceApplicantDecision
K101538Handheld Manual Breast Pump (Avent Manual Breast Pump)HGY · Traditional Philips Electronics UK Limited11/05/2010SE
K013226Evenflo Comfort Ease Manual Breast Pump KitHGY · Traditional Evenflo Company, Inc.12/20/2001SE
K011519Ameda HygienikitHGY · Traditional Hollister, Inc.08/15/2001SE
K971231White River Mini Manual Breast PumpHGY · Traditional White River Concepts05/19/1997SE
K962828Evert-ItHGY · Traditional Genesis Industries, Inc.02/10/1997SE
K952034Medela's Foot PumpHGY · Traditional Medela, Inc.09/12/1995SE
K952035NipletteHGY · Traditional Avent America, Inc.07/28/1995SE
K925738White River Manual Breast PumpHGY · Traditional White River (Tm)05/04/1994SE
K912355Mothers Touch One Hand Breast PumpHGY · Traditional Hollister, Inc.12/10/1993SE
K902552Gerber Precious Care Electric Breast PumpHGY · Traditional Gerber Products Co.09/26/1990SE

More from Gerber Products Co.

510(k)DeviceDecision
K033131Natural Comfort Double Electric/Battery Breast Pump, Model 1181/1068HGX · Special 10/30/2003SE
K032566Natural Comfort Battery/Electric Breast PumpHGX · Special 09/15/2003SE
K964403Simplicity TM Electric/Battery Breast Pump Kit (1068)HGX · Traditional 01/13/1997SE

Questions and answers

When was Easy Comfort Deluxe Manual Breast Pump, Model 1187 cleared by the FDA?

Easy Comfort Deluxe Manual Breast Pump, Model 1187 (K032845) received a 510(k) decision of Substantially Equivalent on April 5, 2004, 207 days after the submission was received.

What is the product code of K032845?

The FDA product code is HGY – Pump, Breast, Non-Powered, a Class I (low risk) device regulated under 21 CFR 884.5150.