STERILE FEEDING TUBE
FDA 510(k) clearance K954218 · decided 1995-11-03
Clearance details
- K-number
- K954218
- Device name
- STERILE FEEDING TUBE
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1995-09-08
- Decision date
- 1995-11-03
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Round Lake, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp
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.
| Record | Firm | Date |
|---|---|---|
| Nutrifit (K243361) | Vygon USA | 2024-12-19 |
| VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (K180236) | Vr Medical Technology Co., Ltd. | 2019-01-18 |
| INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (K131590) | Philips Medical Systems | 2013-10-23 |
| INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (K120815) | Philips Medical Systems | 2013-03-06 |
| NUTRISAFE 2 FEEDING TUBE (K121105) | Vygon Corp. | 2012-12-18 |
| NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (K100163) | Vygon Corp. | 2011-10-13 |
| VR MEDICAL ENTERAL ORAL SYRINGE (K110853) | Vr Medical | 2011-05-13 |
| MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700) | Benlan, Inc. | 2010-12-13 |
| GUARDIAN CONNECTION (K101214) | Maulin Medical, LLC | 2010-07-23 |
| ORAL/ENTERAL SYRINGES (K100099) | Philips Children'S Medical Ventures | 2010-06-14 |
| AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526) | Kentec Medical, Inc. | 2010-04-22 |
| THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 (K091340) | Boston Scientific Corp | 2009-06-09 |
Recalls involving this device
No recalls on record reference this clearance.
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 |