KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE
FDA 510(k) clearance K880850 · decided 1988-05-26
Clearance details
- K-number
- K880850
- Device name
- KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE
- Applicant
- Kmb Medical Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-01
- Decision date
- 1988-05-26
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- FEG
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hazelwood, MO, 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 |
|---|---|---|
| 14Fr Colon Decompression Set, Macon Colon Decompression Set (K171619) | Cook Ireland, Ltd. | 2017-08-01 |
| MEDLINE ANTI-REFLUX VALVE (K132314) | Medline Industries, Inc. | 2013-09-18 |
| GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (K053410) | Kendall | 2006-01-06 |
| NEXT GENERATION SALEM SUMP (K040388) | Kendall | 2004-05-17 |
| KNOTT NG TUBE (K971354) | Michael M. Knott, M.D. | 1997-11-19 |
| DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER (K960176) | C.R. Bard, Inc. | 1996-07-24 |
| ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (K926073) | Surgimark, Inc. | 1995-05-15 |
| ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (K935781) | Sherwood Medical Co. | 1995-01-27 |
| LOPEZ VALVE WITH NG SUMP TUBE (K921104) | Icu Medical, Inc. | 1992-10-26 |
| WILSON-COOK COLON DECOMPRESSION SET (K900035) | Wilson-Cook Medical, Inc. | 1990-03-07 |
| HODGE TUBE (K772282) | Mallinckrodt Critical Care | 1978-03-09 |
| CATHETERS, DRAINAGE (K771048) | Axiom Medical, Inc. | 1977-07-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lum recall (Z-0210-2026) | Cardinal Health 200, LLC | 2025-10-17 |
| (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4. recall (Z-3302-2024) | Cardinal Health 200, LLC | 2024-09-26 |