# K932120: Blom-Singer Indwelling Low Pressure Voice Prosthes

- Pathway: 510(k) (Traditional)
- Applicant: Helix Medical, Inc.
- Decided: Apr 15, 1994 after 347 days
- Product code: EWL (Prosthesis, Laryngeal (Taub))
- Device class: 2
- Regulation: 21 CFR 874.3730
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K991587: Blom-Singer Indwelling 2000 Voice Prosthesis (1999), 1 descendant of its own
- K093258: Blom-Singer Indwelling Tep Occluder (2010), 0 descendants of its own
- K082206: Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series (2008), 0 descendants of its own

## Recalls of this device
- Jun 17, 2026 · Class II · Z-2910-2026: Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large E
- Jun 17, 2026 · Class II · Z-2909-2026: Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large E

Source page: https://510kreport.com/device/K932120
Methodology: https://510kreport.com/methodology