510(k) · Cleared

Cleared

Sepragel Sinus

K012532510(k) TraditionalCleared Oct 30, 200185-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

Genzyme Corp. · LYA Splint, Intranasal Septal

Cleared on Oct 30, 2001 as substantially equivalent to K982731 (Xomed, Inc., 1999) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1997. 47 later devices descend from it.

Decided: Oct 30, 2001
Review: 85 days
Class: Class I
Product code: LYA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K972082 (1997). 3 ancestors in all. 47 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
This deviceK012532 Sepragel SinusGenzyme Corp. · 2001
Descendant · cites it directly · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
Descendant · 2 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
Descendant · 3 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
Descendant · cites it directly · 17 of its ownK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2003high 6 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 47 · See all

K033666HemadermMedafor, Inc. · 2003 · cites it directly29descendants
K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 2 generations on28descendants
K072900Excelarrest FoamHemostasis, LLC · 2007 · 3 generations on19descendants
K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005 · cites it directly17descendants
K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972082	Custom Nasal Splint	Boston Medical Products, Inc.	1997	—
0 (this device)	K012532	Sepragel Sinus	Genzyme Corp.	2001	—
+1	K033666	Hemaderm	Medafor, Inc.	2003	—
+2	K070211	Traumarrest and Bleedarrest Hemostatic Particles and Foam	Hemostasis, LLC	2007	—
+3	K072900	Excelarrest Foam	Hemostasis, LLC	2007	—
+1	K052099	Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ	Polyganics B.V.,	2005	—
+2	K080818	Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing	Hem Con Medical Technologies, Inc.	2008	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	2	0
2007	5	0
2008	3	0
2009	2	0
2010	2	0
2011	1	0
2012	4	0
2013	2	0
2014	6	0
2015	2	0
2016	1	0
2017	2	0
2018	3	0
2019	4	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	1	0

FIG. 1 — Lineage of K012532, 1997–2024Source: 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
*	K982731	Merogel Nasal Dressing and Sinus Stent Summary page 1 …nasal Splint Proprietary name: Hylasine™ 7.5 Legally Marketed Devices to Which Substantial Equivalence is Claimed Xomed MeroGel™ Nasal Dressing and Sinus Stent (Xomed, K982731) Custom Nasal Splint (Boston Medical, K972082) LactoSorb Ethmoid Stent (Walter Lorenz Surgical, K002131) Proprietary and Confide…	Xomed, Inc.	1999	—
*	K972082	Custom Nasal Splint Summary page 1 …Legally Marketed Devices to Which Substantial Equivalence is Claimed Xomed MeroGel™ Nasal Dressing and Sinus Stent (Xomed, K982731) Custom Nasal Splint (Boston Medical, K972082) LactoSorb Ethmoid Stent (Walter Lorenz Surgical, K002131) Proprietary and Confidential Page 23 of 25 W Hylasine…	Boston Medical Products, Inc.	1997	—
*	K002131	Lactosorb Ethmoid Stent Summary page 1 …is Claimed Xomed MeroGel™ Nasal Dressing and Sinus Stent (Xomed, K982731) Custom Nasal Splint (Boston Medical, K972082) LactoSorb Ethmoid Stent (Walter Lorenz Surgical, K002131) Proprietary and Confidential Page 23 of 25 W Hylasine™ Hylan B Gel Premarket [510(k)] Notification 7.6 Descri…	Walter Lorenz Surgical, Inc.	2001	—

Also cleared against K982731: 6 other devices →

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K033666	Hemaderm	Medafor, Inc.	2003	29
K052099	Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ	Polyganics B.V.,	2005	17
K043035	Sepragel Ent Bioresorbable Packing/Stent	Genzyme Corporation	2005	10
K063308	Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200	Carbylan Biosurgery	2006	4
K082276	Synthemed Device	Synthemed, Inc.	2008	3
K070496	Advacoat Sinus Gel and Stent	Carbylan Biosurgery	2007	3

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 3 ancestors has a recall.
Of its descendants, K033666 (Medafor, Inc., 2003) has gone furthest, with 29 descendants of its own.
6 other devices also cite its predicate K982731.

How does its category compare?

All LYA devices

LYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012532 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012532: Sepragel Sinus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012532

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026