Blakemore Tube

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K841038 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Celestin Pulsion Esophogeal Prosthesis

  Class II

  FDA 510(k) K813169 Active Cleared 3 Dec 1981

• Deaver T-Drain & Cattel T-Drain

  Class II

  FDA 510(k) K841034 Active Cleared 13 Apr 1984

• Rectal Balloon Catheters

  Class II

  FDA 510(k) K841036 Active Cleared 13 Apr 1984

• Cole Tube-Latex

  Class II

  FDA 510(k) K840973 Active Cleared 30 Mar 1984

• Nasopharyngeal Airways

  Class I

  FDA 510(k) K841093 Active Cleared 23 Mar 1984

• Four Lumen Blakemore Tube

  Class II

  FDA 510(k) K832672 Active Cleared 12 Sep 1983

See all devices from Inmed Corp. →

• What is the primary purpose of the Blakemore Tube in clinical settings?

  The Blakemore Tube is designed specifically for esophageal decompression and controlling upper gastrointestinal bleeding. Its dual-lumen system allows for gastric aspiration while inflating a balloon to apply pressure against bleeding sites in the esophagus or stomach, helping to stabilize severe cases like variceal hemorrhage.

• Is the Blakemore Tube intended for single-use or repeated use, and how should it be handled?

  The Blakemore Tube is explicitly labeled for single-use only. Since it is non-sterile, it must be sterilized by the facility before use if reuse is required, though the manufacturer does not endorse or validate this practice. Proper sterilization protocols must align with clinical standards to ensure patient safety.

• What storage conditions are recommended to maintain the tube’s integrity before use?

  While the manufacturer does not specify exact storage conditions in the provided data, the non-sterile nature and single-use designation imply it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Clinicians should follow facility protocols to prevent contamination or degradation before use.

• How was the Blakemore Tube’s regulatory pathway determined, and what does that mean for its use?

  The Blakemore Tube received FDA 510(k) clearance under substantial equivalence (SESE) in 1984, meaning it was deemed comparable to a legally marketed device already on the market at the time. This classification places it as a Class II device (product code KNT) under FDA regulations, indicating it requires special controls but does not require pre-market approval. Its use remains governed by clinical judgment and adherence to established medical guidelines.