510(k) Report

510(k) · Cleared

Cleared

Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series

K082206510(k) SpecialCleared Sep 4, 200830-day reviewClass II21 CFR 874.3730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Helix Medical, LLC · EWL Prosthesis, Laryngeal (Taub)

Cleared on Sep 4, 2008 as substantially equivalent to K932120 (Helix Medical, Inc., 1994) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1993.

Decided
Sep 4, 2008
Review
30 days
Class
Class II
Product code
EWL
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K930105 (1993). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 3 other ancestors1997: 1 other ancestor1993: 1 other ancestorK930105 · Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S. · Helix Medical, Inc. · 1993K991587 · Blom-Singer Indwelling 2000 Voice Prosthesis · Helix Medical, Inc. · 199919901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors K991587 · Blom-Singer Indwelling 2000 Voice Prosthesis · Helix Medical, Inc. · 1999K930105 · Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S. · Helix Medical, Inc. · 19930
  1. Root · 2 generations backK930105 Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.Helix Medical, Inc. · 1993
  2. 1 generation backK991587 Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999
  3. This deviceK082206 Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600…Helix Medical, LLC · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K930105Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.Helix Medical, Inc.1993—
−1K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc.1999—
0 (this device)K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series…Helix Medical, LLC2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199430
199710
FIG. 1 — Lineage of K082206, 1993–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EWL device

  1. #1 K240763 FirstFit Surgical Kitscore 9.1 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K932120Blom-Singer Indwelling Low Pressure Voice Prosthes
Summary page 1
….3730 The Blom-Singer Dual Valve Voice Prosthesis is neither a life-supporting nor a life- sustaining device. It is not considered an implant. III PREDICATE DEVICES K932 120, Blom-Singer Indwelling Low Pressure Voice Prosthesis, April 15, 1994 K945287, InHealth Blom-Singer Indwelling Valved Insert, De…
Helix Medical, Inc.19942
*K945287Inhealth Blom-Singer Indwelling Valved Insert Accessory Device
Summary page 1
…or a life- sustaining device. It is not considered an implant. III PREDICATE DEVICES K932 120, Blom-Singer Indwelling Low Pressure Voice Prosthesis, April 15, 1994 K945287, InHealth Blom-Singer Indwelling Valved Insert, December 9, 1994 K99 1587, Blom-Singer Indwelling 2000, June 25, 1999 Related a…
Helix Medical, Inc.1994—
*K991587Blom-Singer Indwelling 2000 Voice Prosthesis
Summary page 1
…DICATE DEVICES K932 120, Blom-Singer Indwelling Low Pressure Voice Prosthesis, April 15, 1994 K945287, InHealth Blom-Singer Indwelling Valved Insert, December 9, 1994 K99 1587, Blom-Singer Indwelling 2000, June 25, 1999 Related accessories being provided with product: -inserter stick -flu…
Helix Medical, Inc.1999—

Also cleared against K932120: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K932120.

How does its category compare?

All EWL devices

EWL Prosthesis, Laryngeal (Taub): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · EWL

1in 2024

2008: 12009: 12010: 22013: 12014: 12024: 1
2007high 2 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EWL

Too few EWL 510(k)s in any year since 2007 to give a median.

Recalls per year · EWL

2so far in 2026, the most since 2007

2013: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EWL

12in 2025

2007: 212008: 102009: 62010: 42012: 42013: 52014: 72015: 112016: 162017: 152019: 72020: 22021: 72022: 52023: 42024: 82025: 12
2007high 21 (2007) · low 0 (2011)2025

MAUDE reports naming product code EWL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—021
20081—010
20091—06
20102—04
20110—00
20120—04
20131—15
20141—07
20150—011
20160—016
20170—015
20180—00
20190—07
20200—02
20210—07
20220—05
20230—04
20241—08
20250—012
20260—2—

What is it indicated for?

The Blom-Singer Indwelling voice prosthesis is indicated for tracheoesophageal voice restoration following total laryngectomy, when placement, or replacement, of an indwelling voice prosthesis is performed by a qualified, trained medical professional.

Indications for use as stated in the FDA summary.

Also cleared against K932120

2 other devices cite the same predicate.

  • K093258Blom-Singer Indwelling Tep OccluderHelix Medical, LLC · 2010
  • K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999

More from Helix Medical, LLC

4 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in EWL

The EWL category page

  • K240763FirstFit Surgical KitFreudenberg Medical, LLC · 2024
  • K141380Provox Freehands FlexivoiceAtos Medical AB · 2014
  • K131947Provox Vega Puncture SetAtos Medical AB · 2013
  • K092593Provox Activalve (Size 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical AB · 2010
  • K093258Blom-Singer Indwelling Tep OccluderHelix Medical, LLC · 2010

https://510kreport.com/device/K082206 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082206: Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082206

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026