Product Code: MPO
FDA class 1
21 CFR 890.5710
Infant Heel Warmer (Chemical Heat Pack)
Physical Medicine
The Infant Heel Warmer (Chemical Heat Pack) is a physical medicine device used to warm the heel of neonates and infants prior to heel-stick blood collection procedures, increasing blood flow to facilitate sample collection. Classified as FDA Class 1 under 21 CFR 890.5710 in the Physical Medicine specialty, it requires 510(k) notification and is eligible for third-party review. The product code is MPO.
510(k)s
11
FEI Numbers
23
Registration Numbers
23
Unique Applicants
11
Years Active
27
Basic Information
- Product Code
- MPO
- Device Class
- FDA class 1
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | Oct 07, 2022 | Substantially Equivalent | International Biomedical |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | Mar 18, 2016 | Substantially Equivalent | COOPERSURGICAL, INC. |
| K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | May 27, 2015 | Substantially Equivalent | RAPID AID CORP. |
| K103549 | DENOVO TEDDY GEL INFANT HEEL WARMER | Apr 08, 2011 | Substantially Equivalent | DENOVO PRODUCTS LLC |
| K053254 | INFANT HEEL WARMER BY INTCO | Sep 19, 2006 | Substantially Equivalent | SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. |
| K040856 | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER | May 03, 2004 | Substantially Equivalent | RAPID AID LTD. |
| K040044 | HEEL SNUGGLER, MODEL 99047 | Jan 27, 2004 | Substantially Equivalent | RESPIRONICS, INC. |
| K032989 | MEDI-HEAT INFANT HEEL WARMER | Oct 22, 2003 | Substantially Equivalent | MEDIHEAT, INC. |
| K964523 | RECOVER INFANT HEEL WARMER (5100) | Feb 10, 1997 | Substantially Equivalent | FLORIDA MEDICAL INDUSTRIES, INC. |
| K961154 | BAXTER SODIUM ACETATE INFANT HEEL WARMER | Jun 06, 1996 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER | Jan 11, 1996 | Substantially Equivalent | DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.