Handheld Manual Breast Pump (Avent Manual Breast Pump)

FDA 510(k) K101538 · Philips Electronics UK Limited

Substantially Equivalent

510(k) numberK101538

Submission

Device name
Handheld Manual Breast Pump (Avent Manual Breast Pump)
Applicant
Philips Electronics UK Limited
Great Abington, Cambridge, GB
Received
June 3, 2010
Decision date
November 5, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
K032845Easy Comfort Deluxe Manual Breast Pump, Model 1187HGY · Traditional The First Years, Inc.04/05/2004SE
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
K100495Philips Avent Digital Thermometer Set, Model SCH540FLL · Traditional 06/22/2010SE
K090167Philips Avent Classic Stage 2 and 3 Teether, Model SCF882/01, SCF884/01, Philips Avent…KKO · Traditional 06/18/2009SE

Questions and answers

When was Handheld Manual Breast Pump (Avent Manual Breast Pump) cleared by the FDA?

Handheld Manual Breast Pump (Avent Manual Breast Pump) (K101538) received a 510(k) decision of Substantially Equivalent on November 5, 2010, 155 days after the submission was received.

What is the product code of K101538?

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