510(k) Report

510(k) · Cleared

Cleared

Shikani Middle Meatal Antrostomy Vent Tube

K912418510(k) TraditionalCleared Dec 20, 1991203-day reviewClass I21 CFR 878.4800

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

Micromedics, Inc. · KAM Cannula, Sinus

Cleared on Dec 20, 1991 after a 203-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Dec 20, 1991
Review
203 days
Class
Class I
Product code
KAM
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK912418 Shikani Middle Meatal Antrostomy Vent TubeMicromedics, Inc. · 1991
  2. Descendant · cites it directly · 3 of its ownK072891 Sinus SpacerAcclarent, Inc. · 2008
  3. Descendant · 2 generations on · 2 of its ownK083574 Relieva Stratus Microflow SpacerAcclarent, Inc. · 2009
  4. Descendant · 3 generations on · 1 of its ownK093594 Modification to Relieva Stratus Microflow SpacerAcclarent, Inc. · 2010
  5. Descendant · 4 generations on · 0 of its ownK110687 Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc. · 2011

Most influential descendants

Showing 4 of 4 · See all
  • K072891Sinus SpacerAcclarent, Inc. · 2008 · cites it directly3descendants
  • K083574Relieva Stratus Microflow SpacerAcclarent, Inc. · 2009 · 2 generations on2descendants
  • K093594Modification to Relieva Stratus Microflow SpacerAcclarent, Inc. · 2010 · 3 generations on1descendant
  • K110687Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc. · 2011 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912418Shikani Middle Meatal Antrostomy Vent TubeMicromedics, Inc.1991—
+1K072891Sinus SpacerAcclarent, Inc.2008—
+2K083574Relieva Stratus Microflow SpacerAcclarent, Inc.2009—
+3K093594Modification to Relieva Stratus Microflow SpacerAcclarent, Inc.2010—
+4K110687Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201110
FIG. 1 — Lineage of K912418, 1991–2011Source: 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 KAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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? (4)

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

NumberDeviceApplicantDecidedDescendants
K072891Sinus SpacerAcclarent, Inc.20083

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, K072891 (Acclarent, Inc., 2008) has gone furthest, with 3 descendants of its own.

How does its category compare?

All KAM devices

KAM Cannula, Sinus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KAM

1in 2011

2007: 12008: 22009: 12010: 12011: 1
2007high 2 (2008) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KAM

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

Recalls per year · KAM

No recall names KAM since 2007.

Adverse event reports per year · KAM

3in 2016

2009: 52010: 122011: 82012: 92013: 72014: 122015: 32016: 3
2007high 12 (2010) · low 0 (2007)2025

MAUDE reports naming product code KAM, 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
20071—00
20082—00
20091—05
20101—012
20111—08
20120—09
20130—07
20140—012
20150—03
20160—03
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Micromedics, Inc.

29 FDA decisions under this applicant name. See the company

  • K241739Endoscopic Applicator, 41 cmMicromedics, Inc. · 2024
  • K123847Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
  • K122526360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K120608Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K102563Single Cannula Extended ApplicatorMicromedics, Inc. · 2011

Recent decisions in KAM

The KAM category page

  • K110687Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc. · 2011
  • K093594Modification to Relieva Stratus Microflow SpacerAcclarent, Inc. · 2010
  • K083574Relieva Stratus Microflow SpacerAcclarent, Inc. · 2009
  • K072891Sinus SpacerAcclarent, Inc. · 2008
  • K073041Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc. · 2008

https://510kreport.com/device/K912418 · printed Nov 5, 2026

Cite this page

510(k) Report. “K912418: Shikani Middle Meatal Antrostomy Vent Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K912418

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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