# K981203: Rusch Blakemore 3 Lumen, Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Jun 5, 1998 after 64 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Rüsch Blakemore Tube - 3 Lumen, non sterile: named in the summary without a submission number

## Recalls of this device
- Mar 4, 2014 · Class II · Z-1506-2014: Sterility of the product cannot be guaranteed.

## Indications for use
The Risch Blakemore Tube - 3 Lumen, Sterile, is a single use, naso-gastric double balloon tube that can be passed nasally into the stomach suitable for use in management of bleeding esophageal varcis

Source page: https://510kreport.com/device/K981203
Methodology: https://510kreport.com/methodology