Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
FDA 510(k) clearance K151845 · decided 2016-03-18
Clearance details
- K-number
- K151845
- Device name
- Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
- Applicant
- CooperSurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-07
- Decision date
- 2016-03-18
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- MPO
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Trumbull, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Infant Heel WarmerTM; Heel Snuggler® (K221154) | International Biomedical | 2022-10-07 |
| Rapid Aid Instant Disposable Infant Heel Warmer (K150627) | Rapid Aid Corp. | 2015-05-27 |
| DENOVO TEDDY GEL INFANT HEEL WARMER (K103549) | Denovo Products, LLC | 2011-04-08 |
| INFANT HEEL WARMER BY INTCO (K053254) | Shanghai Intco Medical Supply Co., Ltd. | 2006-09-19 |
| RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (K040856) | Rapid Aid , Ltd. | 2004-05-03 |
| HEEL SNUGGLER, MODEL 99047 (K040044) | Respironics, Inc. | 2004-01-27 |
| MEDI-HEAT INFANT HEEL WARMER (K032989) | Mediheat, Inc. | 2003-10-22 |
| RECOVER INFANT HEEL WARMER (5100) (K964523) | Florida Medical Industries, Inc. | 1997-02-10 |
| BAXTER SODIUM ACETATE INFANT HEEL WARMER (K961154) | Baxter Healthcare Corp | 1996-06-06 |
| DEROYAL INDUSTRIES INFANT HEEL WARMER (K954716) | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Mara Water Vapor Ablation System (P160047/S039) | CooperSurgical, Inc. | 2025-01-07 |
| MARA Water Vapor Ablation System (P160047/S035) | CooperSurgical, Inc. | 2024-07-11 |
| MARA Water Vapor Ablation System (P160047/S038) | CooperSurgical, Inc. | 2024-07-09 |
| MARA Water Vapor Ablation System (P160047/S036) | CooperSurgical, Inc. | 2024-05-10 |
| Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034) | CooperSurgical, Inc. | 2023-12-08 |
| MARA Water Vapor Ablation System (P160047/S033) | CooperSurgical, Inc. | 2023-10-25 |
| Mara Water Vapor Ablation System (P160047/S031) | CooperSurgical, Inc. | 2023-07-28 |
| Mara Water Vapor Ablation System (P160047/S032) | CooperSurgical, Inc. | 2023-07-27 |