ALL-IN-ONE CONTAINER
FDA 510(k) clearance K090096 · decided 2009-01-30
Clearance details
- K-number
- K090096
- Device name
- ALL-IN-ONE CONTAINER
- Applicant
- Baxter Healthcare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-01-15
- Decision date
- 2009-01-30
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mcgaw Park, IL, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Preveleak Surgical Sealant (P100030/S021) | Baxter Healthcare Corporation | 2025-07-10 |
| PerClot® Polysaccharide Hemostatic System (P210036/S005) | Baxter Healthcare Corporation | 2025-04-25 |
| Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020) | Baxter Healthcare Corporation | 2025-04-11 |
| PerClot Polysaccharide Hemostatic System (P210036/S002) | Baxter Healthcare Corporation | 2024-12-20 |
| Seprafilm Adhesion Barrier (P950034/S059) | Baxter Healthcare Corporation | 2024-12-19 |
| PerClot Polysaccharide Hemostatic System (P210036/S004) | Baxter Healthcare Corporation | 2024-07-18 |
| Seprafilm Adhesion Barrier (P950034/S058) | Baxter Healthcare Corporation | 2024-07-03 |
| Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019) | Baxter Healthcare Corporation | 2024-06-06 |