510(k) · Cleared

Cleared

Synthemed Device

K082276510(k) TraditionalCleared Nov 18, 200899-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

Synthemed, Inc. · LYA Splint, Intranasal Septal

Cleared on Nov 18, 2008 as substantially equivalent to K052099 (Polyganics B.V.,, 2005) and 2 other predicates after a 99-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.

Decided: Nov 18, 2008
Review: 99 days
Class: Class I
Product code: LYA
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K972082 (1997). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
2 generations backK012532 Sepragel SinusGenzyme Corp. · 2001
1 generation backK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
This deviceK082276 Synthemed DeviceSynthemed, Inc. · 2008
Descendant · cites it directly · 1 of its ownK092401 Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc. · 2009
Descendant · 2 generations on · 0 of its ownK170913 Composite Removable Sinus Stent SystemSts Medical · 2017
Descendant · cites it directly · 0 of its ownK160101 SinuBandBioinspire Technologies, Incorporated · 2016

Most influential descendants

Showing 3 of 3 · See all

K092401Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc. · 2009 · cites it directly1descendant
K170913Composite Removable Sinus Stent SystemSts Medical · 2017 · 2 generations on0descendants
K160101SinuBandBioinspire Technologies, Incorporated · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K972082	Custom Nasal Splint	Boston Medical Products, Inc.	1997	—
−2	K012532	Sepragel Sinus	Genzyme Corp.	2001	—
−1	K052099	Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ	Polyganics B.V.,	2005	—
0 (this device)	K082276	Synthemed Device	Synthemed, Inc.	2008	—
+1	K092401	Sinexus Sinus Stent Gen 2, Model 1999-25	Sinexus, Inc.	2009	—
+2	K170913	Composite Removable Sinus Stent System	Sts Medical	2017	—
+1	K160101	SinuBand	Bioinspire Technologies, Incorporated	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2016	1	0
2017	1	0

FIG. 1 — Lineage of K082276, 1997–2017Source: 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? (3)

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
*	K052099	Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ Summary page 1 …on of the physician. Predicate Device(s): The SyntheMed Device is substantially equivalent to the following previously cleared devices. 1. Polyganics Nasospore (K052099) 2. Genzyme Hylasine (K012532) 3. Medtronic Xomed Meropack Nasal Dressing (K041381) Performance Standards: FD…	Polyganics B.V.,	2005	—
*	K012532	Sepragel Sinus Summary page 1 …): The SyntheMed Device is substantially equivalent to the following previously cleared devices. 1. Polyganics Nasospore (K052099) 2. Genzyme Hylasine (K012532) 3. Medtronic Xomed Meropack Nasal Dressing (K041381) Performance Standards: FDA has not established performance stand…	Genzyme Corp.	2001	—
*	K041381	Meropack Bioresorbable Nasal Packing and Sinus Stent Summary page 1 …lowing previously cleared devices. 1. Polyganics Nasospore (K052099) 2. Genzyme Hylasine (K012532) 3. Medtronic Xomed Meropack Nasal Dressing (K041381) Performance Standards: FDA has not established performance standards for this class of device.…	Medtronic Xomed, Inc.	2004	—

Also cleared against K052099: 9 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K092401	Sinexus Sinus Stent Gen 2, Model 1999-25	Sinexus, Inc.	2009	1
K160101	SinuBand	Bioinspire Technologies, Incorporated	2016	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?

The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K092401 (Sinexus, Inc., 2009) has gone furthest, with 1 descendant of its own.
9 other devices also cite its predicate K052099.

How does its category compare?

All LYA devices

LYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082276 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082276: Synthemed Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082276

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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