510(k) Report

510(k) · Cleared

Cleared

Xomed Mandibular Tray

K821904510(k) TraditionalCleared Jul 26, 198228-day reviewClass II21 CFR 874.3695

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

Xomed, Inc. · JAZ Prosthesis, Facial, Mandibular Implant

Cleared on Jul 26, 1982 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 26, 1982
Review
28 days
Class
Class II
Product code
JAZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K821904Source: FDA 510(k) database · 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 JAZ? 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All JAZ devices

JAZ Prosthesis, Facial, Mandibular Implant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAZ

FDA has decided no JAZ device since 2007.

Median 510(k) review, days · JAZ

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

Recalls per year · JAZ

No recall names JAZ since 2007.

Adverse event reports per year · JAZ

1in 2024

2007: 82008: 42009: 72010: 22024: 1
2007high 8 (2007) · low 0 (2011)2025

MAUDE reports naming product code JAZ, 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—08
20080—04
20090—07
20100—02
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

More from Xomed, Inc.

82 FDA decisions under this applicant name. See the company

  • K002395Model 30 Classic PneumatonometerXomed, Inc. · 2000
  • K002987Redtronic Xomed Monopolar Energized BladeXomed, Inc. · 2000
  • K002828XPS Nitro SystemXomed, Inc. · 20001 recall
  • K002897Titanium Middle Ear ProsthesesXomed, Inc. · 20001 recall
  • K993653Micro-France Trocars and AccessoriesXomed, Inc. · 2000

Recent decisions in JAZ

The JAZ category page

  • K901923Invotec Poly-Mesh Mandibular TrayInvotec International, Inc. · 1990

https://510kreport.com/device/K821904 · printed Nov 4, 2026

Cite this page

510(k) Report. “K821904: Xomed Mandibular Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K821904

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026