510(k) Report

510(k) · Cleared

Cleared

Blom-Singer Septal Perforation Prosthesis

K131745510(k) TraditionalCleared Sep 17, 201396-day reviewClass U

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

Helix Medical, LLC · LFB Button, Nasal Septal

Cleared on Sep 17, 2013 as substantially equivalent to K013696 (Silmed, Inc., 2001) and 1 other predicate after a 96-day review. Its family tree reaches back 1 generation to 1981.

Decided
Sep 17, 2013
Review
96 days
Class
Class U
Product code
LFB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K810738 (1981). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK810738 · Goode Magnetic Nasal Splint · Xomed, Inc. · 198119801985199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor K810738 · Goode Magnetic Nasal Splint · Xomed, Inc. · 19810
  1. Root · 1 generation backK810738 Goode Magnetic Nasal SplintXomed, Inc. · 1981
  2. This deviceK131745 Blom-Singer Septal Perforation ProsthesisHelix Medical, LLC · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K810738Goode Magnetic Nasal SplintXomed, Inc.1981—
0 (this device)K131745Blom-Singer Septal Perforation ProsthesisHelix Medical, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K131745, 1981–2013Source: 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 LFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

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
*K013696Silmed Nasal Septal Button
Our reading of the summary gave K013686, FDA’s number for Kodak Directview Tabletop Cassette (Eastman Kodak Company). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Silmed Nasal Septal Button”.
Silmed, Inc.2001—
*K810738Goode Magnetic Nasal Splint
Summary page 1
…Nasal septal button Predicate Devices: KOI 3686 - Silined Nasal Septal Button K8 10738 - Xomed-Treace - Goode-Magne nasal splint IDevice Description: The lorn-Singer®g Septal Perforation Prosthesis is a bi-flanged e…
Xomed, Inc.1981—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All LFB devices

LFB Button, Nasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LFB

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFB

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

Recalls per year · LFB

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · LFB

1in 2021

2017: 12019: 22021: 1
2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code LFB, 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—00
20080—00
20090—00
20100—10
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—02
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Blom-Singer® Septal Perforation Prosthesis is indicated for the non-surgical closure of nasal septal perforations.

Indications for use as stated in the FDA summary.

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
  • 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

Recent decisions in LFB

The LFB category page

  • K013696Silmed Nasal Septal ButtonSilmed, Inc. · 2001
  • K982667Micromedics Nasal Septal ButtonMicromedics, Inc. · 19981 recall
  • K972060Nasal Septal ButtonBoston Medical Products, Inc. · 1997
  • K920994Hood Nasal Septal ButtonHood Laboratories · 1992
  • K901366Invotec Septal ButtonInvotec International, Inc. · 1990

https://510kreport.com/device/K131745 · printed Nov 5, 2026

Cite this page

510(k) Report. “K131745: Blom-Singer Septal Perforation Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131745

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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