510(k) Report

FDA applicant

Helix Medical, Inc.

Santa Barbera, CA18 decisions1989–20132 recalls

FDA records 18 decisions for Helix Medical, Inc. (Santa Barbera, CA) from 1989 to 2013: 18 510(k) clearances. Most are in product codes EWL (Prosthesis, Laryngeal (Taub)) and FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 14 predicates, 8 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Helix Medical, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Helix Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2008: 12010: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Helix Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Helix Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EWLProsthesis, Laryngeal (Taub)12decisions
  • FDFColonoscope And Accessories, Flexible/Rigid1decision
  • LRCInstrument, Ent Manual Surgical1decision
  • LFBButton, Nasal Septal1decision
  • GBWCatheter, Peritoneal1decision
  • JOHTube Tracheostomy And Tube Cuff1decision

Also: BYD (1).

Whose devices does it build on?

Its devices cite 14 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K932120Blom-Singer Indwelling Low Pressure Voice ProsthesHelix Medical, Inc. · 19943cite it
  • K945287Inhealth Blom-Singer Indwelling Valved Insert Accessory DeviceHelix Medical, Inc. · 19941cites it
  • K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 19991cites it
  • K930105Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.Helix Medical, Inc. · 19931cites it
  • K932163Blom-Singer Voice Prosthesis Flushing PipetHelix Medical, Inc. · 19931cites it
  • K023259Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Helix Medical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K130736Blom-Singer Adjustable BI-Fianged Fistula ProsthesisHelix Medical, LLC · 2013
  • K131745Blom-Singer Septal Perforation ProsthesisHelix Medical, LLC · 2013
  • K093258Blom-Singer Indwelling Tep OccluderHelix Medical, LLC · 2010
  • K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC · 2008
  • K023259Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Helix Medical, Inc. · 2002
  • K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999
  • K945287Inhealth Blom-Singer Indwelling Valved Insert Accessory DeviceHelix Medical, Inc. · 1994
  • K945288Inhealth Blom-Singer Indwelling Plug Insert Accessory DeviceHelix Medical, Inc. · 1994

All 14 as Helix Medical, Inc. →All 4 as Helix Medical, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K932120Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LFJun 17, 2026Class II
  • K932120Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEFJun 17, 2026Class II

Other applicant names beginning “Helix”

FDA records each applicant name separately; these may or may not be the same firm.

Helix Diagnostics, Inc. 15Helix Opco, LLC 2