510(k) Report

510(k) · Cleared

Cleared

Blom-Singer Indwelling 2000 Voice Prosthesis

K991587510(k) TraditionalCleared Jun 25, 199949-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, Inc. · EWL Prosthesis, Laryngeal (Taub)

Cleared on Jun 25, 1999 as substantially equivalent to K932120 (Helix Medical, Inc., 1994) and 4 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
Jun 25, 1999
Review
49 days
Class
Class II
Product code
EWL
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K930105 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1994: 2 other ancestors1993: 1 other ancestor2008: 1 descendant clearedK930105 · Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S. · Helix Medical, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K930105 · Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S. · Helix Medical, Inc. · 19930
  1. Root · 1 generation backK930105 Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.Helix Medical, Inc. · 1993
  2. This deviceK991587 Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999
  3. Descendant · cites it directly · 0 of its ownK082206 Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600…Helix Medical, LLC · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930105Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.Helix Medical, Inc.1993—
0 (this device)K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc.1999—
+1K082206Blom-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
199420
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K991587, 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
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What was it cleared against? (6)

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
…in design and indications for use to the following devices currently in commercial distribution: « InHealth Indwelling Voice Prosthesis, Helix Medical, Carpinteria, CA; K932120 » Provox2 Voice Rehabilitation System, ATOS Medical AB, Hoérby, Sweden; K971244 The Blom-Singer Indwelling 2000 Voice Prosthesis…
Helix Medical, Inc.19942
*K971244Provox 2 Voice Prosthesis System
Summary page 1
…al distribution: « InHealth Indwelling Voice Prosthesis, Helix Medical, Carpinteria, CA; K932120 » Provox2 Voice Rehabilitation System, ATOS Medical AB, Hoérby, Sweden; K971244 The Blom-Singer Indwelling 2000 Voice Prosthesis Accessory Devices are either Class I devices not subject to 510(k) or are subst…
Atos Medical AB1997—
*K930105Blom-Singer Low Pressure Voice Prosthesis,P.I.D.S.
Summary page 1
…or are substantially equivalent to the following devices: * InHealth Blom-Singer Low Pressure Voice Prosthesis Gel Cap Insertion System, Helix Medical, Carpinteria, CA; K930105 (Inserter Tool and Gel Caps) * InHealth Blom-Singer Flushing Pipet, Helix (Medical, Carpinteria, CA; K932163 (Flushing Device)…
Helix Medical, Inc.1993—
*K932163Blom-Singer Voice Prosthesis Flushing Pipet
Summary page 1
…s Gel Cap Insertion System, Helix Medical, Carpinteria, CA; K930105 (Inserter Tool and Gel Caps) * InHealth Blom-Singer Flushing Pipet, Helix (Medical, Carpinteria, CA; K932163 (Flushing Device) * InHealth Blom-Singer Indwelling Plug Insert Accessory Device, Helix Medical, Carpinteria, CA; K945288 (Plug…
Helix Medical, Inc.1993—
*K945288Inhealth Blom-Singer Indwelling Plug Insert Accessory Device
Summary page 1
…ushing Pipet, Helix (Medical, Carpinteria, CA; K932163 (Flushing Device) * InHealth Blom-Singer Indwelling Plug Insert Accessory Device, Helix Medical, Carpinteria, CA; K945288 (Plug Insert) IV. DESCRIPTION The design of the Blom-Singer Indwelling 2000 Voice Prosthesis is substantially equivalent to the…
Helix Medical, Inc.1994—
*—Blom-Singer Indwelling Low Pressure Voice Prosthesis
Named without a submission number
—

Also cleared against K932120: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC20080

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K082206 (Helix Medical, LLC, 2008) has gone furthest, with 0 descendants of its own.
  • 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.

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 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement/replacement of the voice prosthesis is done by a clinician. The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K932120

2 other devices cite the same predicate.

  • 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

More from Helix Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • K023259Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Helix Medical, Inc. · 2002
  • K945287Inhealth Blom-Singer Indwelling Valved Insert Accessory DeviceHelix Medical, Inc. · 1994
  • K945288Inhealth Blom-Singer Indwelling Plug Insert Accessory DeviceHelix Medical, Inc. · 1994
  • K932120Blom-Singer Indwelling Low Pressure Voice ProsthesHelix Medical, Inc. · 19942 recalls
  • K932163Blom-Singer Voice Prosthesis Flushing PipetHelix Medical, Inc. · 1993

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/K991587 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991587: Blom-Singer Indwelling 2000 Voice Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991587

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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