510(k) Report

510(k) · Cleared

Cleared

Robinson Middle Ear Prosthesis

K760570510(k) TraditionalCleared Sep 21, 197620-day reviewClass I21 CFR 872.4565

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

Xomed, Inc. · EIB Syringe, Irrigating (Dental)

Cleared on Sep 21, 1976 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 21, 1976
Review
20 days
Class
Class I
Product code
EIB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K760570Source: 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.

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  • 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 EIB devices

EIB Syringe, Irrigating (Dental): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIB

FDA has decided no EIB device since 2007.

Median 510(k) review, days · EIB

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

Recalls per year · EIB

No recall names EIB since 2007.

Adverse event reports per year · EIB

1in 2025

2016: 12025: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code EIB, 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
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
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 EIB

The EIB category page

  • K911118DTF-1000LL,DTF-1000Cp Medical · 1991
  • K874543Model Opo-32 Irrigation SleeveAllergan, Inc. · 1988
  • K822411System 80 Faceplate-in-the-Ear #F1Western Advanced Technology, Inc. · 1983

https://510kreport.com/device/K760570 · printed Nov 5, 2026

Cite this page

510(k) Report. “K760570: Robinson Middle Ear Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K760570

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