510(k) Report

510(k) · Cleared

Cleared

Inhealth Blom-Singer Indwelling Plug Insert Accessory Device

K945288510(k) TraditionalCleared Dec 2, 199432-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 Dec 2, 1994 after a 32-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Dec 2, 1994
Review
32 days
Class
Class II
Product code
EWL
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2008: 1 descendant cleared1990200020102020
  1. This deviceK945288 Inhealth Blom-Singer Indwelling Plug Insert Accessory DeviceHelix Medical, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK991587 Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999
  3. Descendant · 2 generations on · 0 of its ownK082206 Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600…Helix Medical, LLC · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999 · cites it directly1descendant
  • K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945288Inhealth Blom-Singer Indwelling Plug Insert Accessory DeviceHelix Medical, Inc.1994—
+1K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc.1999—
+2K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series…Helix Medical, LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200810
FIG. 1 — Lineage of K945288, 1994–2008Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc.19991

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?

  • Of its descendants, K991587 (Helix Medical, Inc., 1999) has gone furthest, with 1 descendant of its own.

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—

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
  • K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999
  • K945287Inhealth Blom-Singer Indwelling Valved 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/K945288 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945288: Inhealth Blom-Singer Indwelling Plug Insert Accessory Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945288

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026