510(k) · Cleared

Cleared

ALAR Nasal Valve Stent

K151758510(k) TraditionalCleared Oct 29, 2015122-day reviewClass II21 CFR 878.5000

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

Medtronic Xomed, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Oct 29, 2015 as substantially equivalent to K021019 (Genzyme Corp., 2002) after a 122-day review. Its family tree reaches back 2 generations to 1994.

Decided: Oct 29, 2015
Review: 122 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K930738 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
1 generation backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
This deviceK151758 ALAR Nasal Valve StentMedtronic Xomed, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K930738	Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc	Deknatel, Inc.	1994	9
−1	K021019	Cottony II, Silky II Polydek & Tevdek II Polyester Suture	Genzyme Corp.	2002	7
0 (this device)	K151758	ALAR Nasal Valve Stent	Medtronic Xomed, Inc.	2015	—

FIG. 1 — Lineage of K151758, 1994–2015Source: 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 GAT? 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 GAT device

#1 K230311 HyperSuturescore 20.2 · 7 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
*	K021019	Cottony II, Silky II Polydek & Tevdek II Polyester Suture Summary page 4 …hthalate) surgical suture (21 CFR 878.5000) IV. Classification: Class II V. Predicate Devices: K021019 Tevdek® Suture with Needle (GAT) Class I Exempt Medtronic Xomed Internal Nasal Splints…	Genzyme Corp.	2002	7
*	—	Medtronic Xomed Internal Nasal Splints Named without a submission number			—

Also cleared against K021019: 11 other devices →

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?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 13.4 years on median.
2 of the 2 ancestors have a recall of any class.
11 other devices also cite its predicate K021019.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GAT

5in 2025

2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · GAT

2,956in 2025

2007high 2,956 (2025) · low 15 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	40	1	15
2008	4	93	0	15
2009	9	57	0	55
2010	11	27	3	79
2011	1	—	1	97
2012	6	61	0	253
2013	4	123	0	210
2014	4	45	0	165
2015	7	125	0	626
2016	10	139	0	688
2017	6	57	0	1,104
2018	6	95	0	1,453
2019	4	79	0	1,251
2020	5	201	0	1,220
2021	4	92	0	1,643
2022	5	109	0	1,419
2023	8	220	0	2,038
2024	3	140	0	2,597
2025	5	30	0	2,956
2026	5	83	0	—

What is it indicated for?

The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151758: ALAR Nasal Valve Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151758

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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