510(k) Report

510(k) · Cleared

Cleared

Hood Nasal Septal Button

K920994510(k) TraditionalCleared May 15, 199274-day reviewClass U

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

Hood Laboratories · LFB Button, Nasal Septal

Cleared on May 15, 1992 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 15, 1992
Review
74 days
Class
Class U
Product code
LFB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K920994Source: FDA 510(k) database · 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 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?

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

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.

How does its category compare?

All LFB devices

LFB Button, Nasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Hood Laboratories

19 FDA decisions under this applicant name. See the company

  • K921452Acoustic RhinometerHood Laboratories · 1993
  • K905703Krupin Eye Valve with DiskHood Laboratories · 19914 recalls
  • K904821Eliachar Modified Esophageal StentHood Laboratories · 1991
  • K897049Gibson Endolymphatic ShuntHood Laboratories · 1990
  • K897059Hood Speaking ValveHood Laboratories · 1990

Recent decisions in LFB

The LFB category page

  • K131745Blom-Singer Septal Perforation ProsthesisHelix Medical, LLC · 2013
  • K013696Silmed Nasal Septal ButtonSilmed, Inc. · 2001
  • K982667Micromedics Nasal Septal ButtonMicromedics, Inc. · 19981 recall
  • K972060Nasal Septal ButtonBoston Medical Products, Inc. · 1997
  • K901366Invotec Septal ButtonInvotec International, Inc. · 1990

https://510kreport.com/device/K920994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920994: Hood Nasal Septal Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920994

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