Evenflo Company, Inc. FDA Record
Evenflo Company, Inc. has 0 FDA recalls, 3 inspections, 11 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Evenflo Company, Inc., the most recent on Aug 25, 2009.
- Latest inspection
- Jan 17, 2013 · NAI
- Latest 510(k)
- Dec 22, 2010
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 11 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Evenflo Company, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 25, 2009 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 17, 2013 | Miamisburg, OH | Devices | No Action Indicated (NAI) | 3001329238 |
| Mar 4, 2010 | Miamisburg, OH | Devices | No Action Indicated (NAI) | 3001329238 |
| Feb 2, 2009 | Miamisburg, OH | Devices | Official Action Indicated (OAI) | 3001329238 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Evenflo Company, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3001329238 | Miamisburg, OH | 3 | Jan 17, 2013 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K102600 | SIMPLYGO BREAST PUMP | Dec 22, 2010 |
| K100435 | AMEDA PLATINUM BREAST PUMP | May 28, 2010 |
| K092770 | SIMPLYGO HANDS FREE BREAST PUMP | Oct 9, 2009 |
| K082307 | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT | Sep 11, 2008 |
| K053493 | BERRY FRUITY TEETHER | Feb 22, 2006 |
| K052909 | EVENFLO ELAN BREAST PUMP | Nov 1, 2005 |
| K022933 | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT | Dec 2, 2002 |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Dec 20, 2001 |
| K983776 | EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP | Apr 26, 1999 |
| K960727 | EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT | Feb 14, 1997 |
| K960726 | EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP | Jul 22, 1996 |
Evenflo Company, Inc. and the FDA: common questions
Has Evenflo Company, Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Evenflo Company, Inc.. The most recent is dated Aug 25, 2009.
Has Evenflo Company, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Evenflo Company, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Evenflo Company, Inc.?
The most recent FDA inspection on file ended Jan 17, 2013 at Miamisburg, OH and was classified NAI. FDA has 3 inspections of Evenflo Company, Inc. on file, 1 of them classified OAI (official action indicated).
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