FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K Number: K151845
·
Decision Mar 18, 2016
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
41
Review Days
255
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
- K Number
- K151845
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CooperSurgical, Inc.
- Date Received
- July 7, 2015
- Decision Date
- March 18, 2016
- Product Code
- MPO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MPO | Infant Heel Warmer (Chemical Heat Pack) | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MPO), ordered by most recent decision date.
Infant Heel WarmerTM; Heel Snuggler®
FDA 510(k)
FDA Class 1
·Physical Medicine
Rapid Aid Instant Disposable Infant Heel Warmer
FDA 510(k)
FDA Class 1
·Physical Medicine
DENOVO TEDDY GEL INFANT HEEL WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
INFANT HEEL WARMER BY INTCO
FDA 510(k)
FDA Class 1
·Physical Medicine
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
HEEL SNUGGLER, MODEL 99047
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by CooperSurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243799 | Fetal Pillow | Aug 29, 2025 | Substantially Equivalent |
| K250438 | CooperSurgical Milex® Pessaries | Apr 11, 2025 | Substantially Equivalent |
| K223064 | ALLY II Uterine Positioning System (UPS) | Oct 28, 2022 | Substantially Equivalent |
| K201086 | Advincula Delineator Uterine Manipulator | May 21, 2020 | Substantially Equivalent |
| K200038 | Endosee System | Feb 5, 2020 | Substantially Equivalent |
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | Jan 14, 2020 | Substantially Equivalent |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | Jun 12, 2019 | Substantially Equivalent |
| K190639 | Endosee System | May 15, 2019 | Substantially Equivalent |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | May 10, 2019 | Substantially Equivalent |
| K183020 | Endosee System | Jan 31, 2019 | Substantially Equivalent |