BAXTER SODIUM ACETATE INFANT HEEL WARMER
FDA 510(k) clearance K961154 · decided 1996-06-06
Clearance details
- K-number
- K961154
- Device name
- BAXTER SODIUM ACETATE INFANT HEEL WARMER
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1996-03-22
- Decision date
- 1996-06-06
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- MPO
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mcgaw Park, IL, 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 |
| Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (K151845) | CooperSurgical, Inc. | 2016-03-18 |
| 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 |
| DEROYAL INDUSTRIES INFANT HEEL WARMER (K954716) | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 recall (Z-2147-2023) | Cardinal Health 200, LLC | 2023-07-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |