# K093258: Blom-Singer Indwelling Tep Occluder

- Pathway: 510(k) (Special)
- Applicant: Helix Medical, LLC
- Decided: Mar 3, 2010 after 135 days
- Product code: EWL (Prosthesis, Laryngeal (Taub))
- Device class: 2
- Regulation: 21 CFR 874.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K812982 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932120: Blom-Singer Indwelling Low Pressure Voice Prosthes, Helix Medical, Inc. (1994) Summary page 1.
- K812982: Blom-Singer Voice Prosthesis, Bivona Medical Technologies (1981) Summary page 1.

## Indications for use
The Blom-Singer Indwelling TEP Occluder is indicated for anterograde placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of the indwelling occluder is performed by a qualified, trained medical professional. This device is for use with healed, intact tracheoesophageal puncture fistulas only.

Source page: https://510kreport.com/device/K093258
Methodology: https://510kreport.com/methodology