510(k) Report

510(k) · Cleared

Cleared

Lactosorb Ethmoid Stent

K002131510(k) TraditionalCleared Apr 13, 2001273-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

Walter Lorenz Surgical, Inc. · LYA Splint, Intranasal Septal

Cleared on Apr 13, 2001 after a 273-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.

Decided
Apr 13, 2001
Review
273 days
Class
Class I
Product code
LYA
Recalls
None
Predicates
0

50 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2013: 3 descendants cleared2009: 2 descendants cleared2005: 2 descendants cleared2003: 1 descendant cleared2007: 5 descendants cleared2006: 2 descendants cleared2008: 3 descendants cleared2017: 2 descendants cleared2025: 1 descendant cleared2012: 4 descendants cleared2010: 2 descendants cleared2014: 6 descendants cleared2020: 1 descendant cleared2016: 1 descendant cleared2011: 1 descendant cleared2022: 1 descendant cleared2015: 2 descendants cleared2019: 4 descendants cleared2018: 3 descendants cleared2024: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK002131 Lactosorb Ethmoid StentWalter Lorenz Surgical, Inc. · 2001
  2. Descendant · cites it directly · 47 of its ownK012532 Sepragel SinusGenzyme Corp. · 2001
  3. Descendant · 2 generations on · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
  4. Descendant · 3 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
  5. Descendant · 4 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
  6. Descendant · 2 generations on · 17 of its ownK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2001: 12003: 12005: 22006: 22007: 52008: 32009: 22010: 22011: 12012: 42013: 32014: 62015: 22016: 12017: 22018: 32019: 42020: 12021: 12022: 12023: 12024: 12025: 1
2001high 6 (2014) · low 0 (2002)2026

Most influential descendants

Showing 5 of 50 · See all
  • K012532Sepragel SinusGenzyme Corp. · 2001 · cites it directly47descendants
  • K033666HemadermMedafor, Inc. · 2003 · 2 generations on29descendants
  • K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 3 generations on28descendants
  • K072900Excelarrest FoamHemostasis, LLC · 2007 · 4 generations on19descendants
  • K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005 · 2 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002131Lactosorb Ethmoid StentWalter Lorenz Surgical, Inc.2001—
+1K012532Sepragel SinusGenzyme Corp.2001—
+2K033666HemadermMedafor, Inc.2003—
+3K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC2007—
+4K072900Excelarrest FoamHemostasis, LLC2007—
+2K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V.,2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200520
200620
200750
200830
200920
201020
201110
201240
201330
201460
201520
201610
201720
201830
201940
202010
202110
202210
202310
202410
202510
FIG. 1 — Lineage of K002131, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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. #1 K243655 TurbAlignscore 10.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (50)

See all 50

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

NumberDeviceApplicantDecidedDescendants
K012532Sepragel SinusGenzyme Corp.200147
K130354Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair)Entrigue Surgical, Inc.20131
K092401Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc.20091

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, K012532 (Genzyme Corp., 2001) has gone furthest, with 47 descendants of its own.

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

2007: 12008: 22009: 12012: 12013: 22014: 52016: 12017: 22018: 22020: 12021: 12023: 12025: 1
2007high 5 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYA

104in 2014

2014: 104 days median
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

2007: 22009: 52010: 22011: 162012: 162013: 12014: 42015: 282016: 282017: 102018: 192019: 52020: 62021: 192022: 82023: 172024: 72025: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20082—00
20091—05
20100—02
20110—016
20121—016
20132—01
2014510404
20150—028
20161—028
20172—010
20182—019
20190—05
20201—06
20211—019
20220—08
20231—017
20240—07
20251—01
20260—0—

More from Walter Lorenz Surgical, Inc.

56 FDA decisions under this applicant name. See the company

  • K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc. · 2007
  • K063052Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
  • K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  • K062842Twist DrillWalter Lorenz Surgical, Inc. · 20061 recall
  • K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumWalter Lorenz Surgical, Inc. · 2006

Recent decisions in LYA

The LYA category page

  • K243655TurbAlignSpirair, Inc. · 2025
  • K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023
  • K213153SPIWay Endonasal Access GuideSpiway, LLC · 2021
  • K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed · 2020
  • K181696ChitoZolveGyrus Acmi, Inc. · 2018

https://510kreport.com/device/K002131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002131: Lactosorb Ethmoid Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002131

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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