510(k) · Cleared

Cleared

Lorenz Stent

K896667510(k) TraditionalCleared Feb 22, 199087-day reviewClass II21 CFR 874.3620

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. · FWN Prosthesis, Larynx (Stents And Keels)

Cleared on Feb 22, 1990 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Feb 22, 1990
Review: 87 days
Class: Class II
Product code: FWN
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK896667 Lorenz StentWalter Lorenz Surgical, Inc. · 1990
Descendant · cites it directly · 0 of its ownK012409 Lorenz Lactosorb Laryngotracheal Reconstruction ImplantsWalter Lorenz Surgical, Inc. · 2001

Most influential descendants

Showing 1 of 1 · See all

K012409Lorenz Lactosorb Laryngotracheal Reconstruction ImplantsWalter Lorenz Surgical, Inc. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K896667	Lorenz Stent	Walter Lorenz Surgical, Inc.	1990	—
+1	K012409	Lorenz Lactosorb Laryngotracheal Reconstruction Implants	Walter Lorenz Surgical, Inc.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K896667, 1990–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FWN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012409	Lorenz Lactosorb Laryngotracheal Reconstruction Implants	Walter Lorenz Surgical, Inc.	2001	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?

Of its descendants, K012409 (Walter Lorenz Surgical, Inc., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FWN devices

FWN Prosthesis, Larynx (Stents And Keels): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWN

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FWN

Too few FWN 510(k)s in any year since 2007 to give a median.

Recalls per year · FWN

No recall names FWN since 2007.

Adverse event reports per year · FWN

2in 2018

2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code FWN, 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	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	1
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	2
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K896667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896667: Lorenz Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896667

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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