Blom-Singer Low Pressure Voice Prosthesis

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Blom-Singer Low Pressure Voice Prosthes

510(k) Number

K842896 ↗

FDA Product Code

EWL

Device Class

Class II

Regulation

21 CFR Part 874.3730

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap

  Class I

  FDA 510(k) K854568 Active Cleared 2 Dec 1985

• Gauderer Gastrostomy Button

  Class II

  FDA 510(k) K843392 Active Cleared 11 Oct 1984

• Heyer-Schulte(R) One Piece Shunt Vent. Cath. Intro

  Class I

  FDA 510(k) K873771 Active Cleared 18 Dec 1987

• Field-Lee Brain Biopsy Needle

  Class I

  FDA 510(k) K801760 Active Cleared 9 Sep 1980

• V-Mueller Inverted Linear Anastomosis Instruments

  Class II

  FDA 510(k) K850947 Active Cleared 17 Apr 1985

• Laser Mirror

  Not classified

  FDA 510(k) K840982 Active Cleared 6 Mar 1984

See all devices from American V. Mueller →

• What is the Blom-Singer Low Pressure Voice Prosthesis used for?

  This device is a laryngeal voice prosthesis designed to restore speech after laryngectomy by allowing exhaled air from the trachea to pass through the prosthesis into the esophagus and out the mouth, following temporary stoma occlusion. It enables tracheoesophageal speech for patients who have undergone total laryngectomy.

• How is the Blom-Singer Low Pressure Voice Prosthesis supplied and is it sterile or reusable?

  The device is supplied as a single unit per the provided data. It is not described as sterile, reusable, or MRI-safe in the device information. Therefore, it should be treated as a non-sterile, single-use device unless otherwise specified by the manufacturer's labeling, which is not included in this data.

• What regulatory pathway was used for the Blom-Singer Low Pressure Voice Prosthesis and when was it cleared?

  The Blom-Singer Low Pressure Voice Prosthesis was cleared through the FDA 510(k) process under submission K842896, with a decision date of August 17, 1984. It was found substantially equivalent to a predicate device and is classified as a Class II medical device under regulation 874.3730.