510(k) Report

510(k) · Cleared

Cleared

Serenocem, Model BC 010

K003567510(k) TraditionalCleared Feb 12, 200184-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

Corinthian Medical, Ltd. · NEA Cement, Ear, Nose And Throat

Cleared on Feb 12, 2001 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 12, 2001
Review
84 days
Class
Class II
Product code
NEA
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2008: 1 descendant cleared200020052010201520202025
  1. This deviceK003567 Serenocem, Model BC 010Corinthian Medical, Ltd. · 2001
  2. Descendant · cites it directly · 1 of its ownK080032 Envoycem, Model 1640Envoy Medical Corporation · 2008
  3. Descendant · cites it directly · 0 of its ownK140644 ProcemOtotronix, LLC · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K080032Envoycem, Model 1640Envoy Medical Corporation · 2008 · cites it directly1descendant
  • K140644ProcemOtotronix, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003567Serenocem, Model BC 010Corinthian Medical, Ltd.2001—
+1K080032Envoycem, Model 1640Envoy Medical Corporation2008—
+1K140644ProcemOtotronix, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201410
FIG. 1 — Lineage of K003567, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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?

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

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K080032Envoycem, Model 1640Envoy Medical Corporation20081
K140644ProcemOtotronix, LLC20140

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, K080032 (Envoy Medical Corporation, 2008) has gone furthest, with 1 descendant of its own.

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.

FDA decisions per year · NEA

1in 2014

2008: 12014: 1
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

2013: 12014: 22017: 82018: 22019: 92020: 32023: 92024: 52025: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—00
20110—00
20120—00
20130—01
20141—02
20150—00
20160—00
20170—08
20180—02
20190—09
20200—03
20210—00
20220—00
20230—09
20240—05
20250—02
20260—0—

Recent decisions in NEA

The NEA category page

  • K140644ProcemOtotronix, LLC · 2014
  • K080032Envoycem, Model 1640Envoy Medical Corporation · 2008
  • K060750Stryker Injectable CementStryker Cmf · 2006
  • K042516OtomimixWalter Lorenz Surgical, Inc. · 2004
  • K011338Oto-CemOtotech, Inc. · 2001

https://510kreport.com/device/K003567 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003567: Serenocem, Model BC 010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003567

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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