Evenflo Comfort Ease Manual Breast Pump Kit
FDA 510(k) K013226 · Evenflo Company, Inc.
510(k) numberK013226
Submission
- Device name
- Evenflo Comfort Ease Manual Breast Pump Kit
- Applicant
- Evenflo Company, Inc.
Canton, GA, US - Received
- September 27, 2001
- Decision date
- December 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K101538 | Handheld Manual Breast Pump (Avent Manual Breast Pump)HGY · Traditional | Philips Electronics UK Limited | 11/05/2010SE |
| K032845 | Easy Comfort Deluxe Manual Breast Pump, Model 1187HGY · Traditional | The First Years, Inc. | 04/05/2004SE |
| K011519 | Ameda HygienikitHGY · Traditional | Hollister, Inc. | 08/15/2001SE |
| K971231 | White River Mini Manual Breast PumpHGY · Traditional | White River Concepts | 05/19/1997SE |
| K962828 | Evert-ItHGY · Traditional | Genesis Industries, Inc. | 02/10/1997SE |
| K952034 | Medela's Foot PumpHGY · Traditional | Medela, Inc. | 09/12/1995SE |
| K952035 | NipletteHGY · Traditional | Avent America, Inc. | 07/28/1995SE |
| K925738 | White River Manual Breast PumpHGY · Traditional | White River (Tm) | 05/04/1994SE |
| K912355 | Mothers Touch One Hand Breast PumpHGY · Traditional | Hollister, Inc. | 12/10/1993SE |
| K902552 | Gerber Precious Care Electric Breast PumpHGY · Traditional | Gerber Products Co. | 09/26/1990SE |
More from Gerber Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K102600 | Simplygo Breast PumpHGX · Special | 12/22/2010SE |
| K100435 | Ameda Platinum Breast PumpHGX · Traditional | 05/28/2010SE |
| K092770 | Simplygo Hands Free Breast PumpHGX · Special | 10/09/2009SE |
| K082307 | Evenflo Comfort Select Performance Breast Pump KitHGX · Special | 09/11/2008SE |
| K053493 | Berry Fruity TeetherKKO · Traditional | 02/22/2006SE |
| K052909 | Evenflo Elan Breast PumpHGX · Traditional | 11/01/2005SE |
| K022933 | Evenflo Comfort Select Auto-Cycle Breast Pump KitHGX · Traditional | 12/02/2002SE |
| K983776 | Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast PumpHGX · Traditional | 04/26/1999SE |
| K960727 | Evenflo Natural Mother Electric Breast Pump KitHGX · Traditional | 02/14/1997SE |
| K960726 | Evenflo Soft-Touch Ultra Battery Operated Breast PumpHGX · Traditional | 07/22/1996SE |
Questions and answers
When was Evenflo Comfort Ease Manual Breast Pump Kit cleared by the FDA?
Evenflo Comfort Ease Manual Breast Pump Kit (K013226) received a 510(k) decision of Substantially Equivalent on December 20, 2001, 84 days after the submission was received.
What is the product code of K013226?
The FDA product code is HGY – Pump, Breast, Non-Powered, a Class I (low risk) device regulated under 21 CFR 884.5150.