510(k) · Cleared

Cleared

Envoycem, Model 1640

K080032510(k) TraditionalCleared Feb 28, 200852-day reviewClass II21 CFR 872.3275

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

Envoy Medical Corporation · NEA Cement, Ear, Nose And Throat

Cleared on Feb 28, 2008 as substantially equivalent to K011338 (Ototech, Inc., 2001) and 2 other predicates after a 52-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.

Decided: Feb 28, 2008
Review: 52 days
Class: Class II
Product code: NEA
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K861369 (1986). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK861369 Incus/Stapes ProsthesisRichards Medical Co., Inc. · 1986
1 generation backK042516 OtomimixWalter Lorenz Surgical, Inc. · 2004
This deviceK080032 Envoycem, Model 1640Envoy Medical Corporation · 2008
Descendant · cites it directly · 0 of its ownK140644 ProcemOtotronix, LLC · 2014

Most influential descendants

Showing 1 of 1 · See all

K140644ProcemOtotronix, LLC · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K861369	Incus/Stapes Prosthesis	Richards Medical Co., Inc.	1986	—
−1	K042516	Otomimix	Walter Lorenz Surgical, Inc.	2004	—
0 (this device)	K080032	Envoycem, Model 1640	Envoy Medical Corporation	2008	—
+1	K140644	Procem	Ototronix, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K080032, 1986–2014Source: 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 NEA? 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? (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
*	K011338	Oto-Cem	Ototech, Inc.	2001	—
*	K003567	Serenocem, Model BC 010 Summary page 1 …ent devices Envoy Medical believes that EnvoyCem is substantially equivalent to the following devices: OTO-CEM, KOI 1338 SerenoCem, K003567 OtoMimix, K042516 EnvoyCem is glass ionomer cement as is OTO-CEM and SerenoCem and has essentially the s…	Corinthian Medical, Ltd.	2001	—
*	K042516	Otomimix Summary page 1 …elieves that EnvoyCem is substantially equivalent to the following devices: OTO-CEM, KOI 1338 SerenoCem, K003567 OtoMimix, K042516 EnvoyCem is glass ionomer cement as is OTO-CEM and SerenoCem and has essentially the same intended use as all three of…	Walter Lorenz Surgical, Inc.	2004	—

Also cleared against K011338: 1 other device →

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
K140644	Procem	Ototronix, LLC	2014	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 22 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K140644 (Ototronix, LLC, 2014) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011338.

How does its category compare?

All NEA devices

NEA Cement, Ear, Nose And Throat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NEA

1in 2014

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEA

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

Recalls per year · NEA

No recall names NEA since 2007.

Adverse event reports per year · NEA

2in 2025

2007high 9 (2019) · low 0 (2007)2025

MAUDE reports naming product code NEA, 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	1	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	1	—	2
2015	0	—	0
2016	0	—	0
2017	0	—	8
2018	0	—	2
2019	0	—	9
2020	0	—	3
2021	0	—	0
2022	0	—	0
2023	0	—	9
2024	0	—	5
2025	0	—	2
2026	0	—	—

What is it indicated for?

EnvoyCem is intended for use in otologic surgery for the following applications:

* Augmentation or coupling of the middle ear ossicles.

* Attachment of the middle ear ossicles to middle ear implants.

* Mechanical stabilization of middle ear prostheses.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080032 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080032: Envoycem, Model 1640.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080032

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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