510(k) · Cleared

Cleared

Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair)

K130354510(k) TraditionalCleared May 29, 2013106-day reviewClass I21 CFR 874.4780

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

Entrigue Surgical, Inc. · LYA Splint, Intranasal Septal

Cleared on May 29, 2013 as substantially equivalent to K002131 (Walter Lorenz Surgical, Inc., 2001) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: May 29, 2013
Review: 106 days
Class: Class I
Product code: LYA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K002131 (2001). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002131 Lactosorb Ethmoid StentWalter Lorenz Surgical, Inc. · 2001
This deviceK130354 Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4…Entrigue Surgical, Inc. · 2013
Descendant · cites it directly · 0 of its ownK243655 TurbAlignSpirair, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all

K243655TurbAlignSpirair, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002131	Lactosorb Ethmoid Stent	Walter Lorenz Surgical, Inc.	2001	—
0 (this device)	K130354	Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair)	Entrigue Surgical, Inc.	2013	—
+1	K243655	TurbAlign	Spirair, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K130354, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LYA? 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 LYA device

#1 K243655 TurbAlignscore 10.0 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002131	Lactosorb Ethmoid Stent Summary page 1 …R. § 874.4780) Classification: Class I Predicate Devices: Walter Lorenz Surgical Inc., LactoSorb® Ethmoid Stent [K002131] Medtronic Xomed Inc., MeroPack TM Nasal Packing and Sinus Stent [K04…	Walter Lorenz Surgical, Inc.	2001	—
*	K041381	Meropack Bioresorbable Nasal Packing and Sinus Stent Summary page 1 …tent [K002131] Medtronic Xomed Inc., MeroPack TM Nasal Packing and Sinus Stent [K041 381] Intended Use/ The MedliENTO Middle Turbinate Implant is intended to Indications for Use: separate the…	Medtronic Xomed, Inc.	2004	—

Also cleared against K002131: 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.

Number	Device	Applicant	Decided	Descendants
K243655	TurbAlign	Spirair, Inc.	2025	0

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.
Of its descendants, K243655 (Spirair, Inc., 2025) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K002131.

How does its category compare?

All LYA devices

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

FDA decisions per year · LYA

1in 2025

2007high 5 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYA

104in 2014

2007high 104 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYA

No recall names LYA since 2007.

Adverse event reports per year · LYA

1in 2025

2007high 28 (2015) · low 0 (2008)2025

MAUDE reports naming product code LYA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	2
2008	2	—	0
2009	1	—	5
2010	0	—	2
2011	0	—	16
2012	1	—	16
2013	2	—	1
2014	5	104	4
2015	0	—	28
2016	1	—	28
2017	2	—	10
2018	2	—	19
2019	0	—	5
2020	1	—	6
2021	1	—	19
2022	0	—	8
2023	1	—	17
2024	0	—	7
2025	1	—	1
2026	0	—	—

What is it indicated for?

The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130354 · printed Nov 4, 2026

Cite this page

510(k) Report. “K130354: Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130354

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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