510(k) Report

510(k) · Cleared

Cleared

IE Magnetic Extractor

K904668510(k) TraditionalCleared Mar 21, 1991157-day reviewClass II21 CFR 876.1500

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

Olympus Corp. · FCC Endoscopic Magnetic Retriever

Cleared on Mar 21, 1991 after a 157-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 21, 1991
Review
157 days
Class
Class II
Product code
FCC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K904668Source: 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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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 FCC devices

FCC Endoscopic Magnetic Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCC

FDA has decided no FCC device since 2007.

Median 510(k) review, days · FCC

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

Recalls per year · FCC

No recall names FCC since 2007.

Adverse event reports per year · FCC

No MAUDE report names FCC since 2007.

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—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Olympus Corp.

142 FDA decisions under this applicant name. See the company

  • K915402EW-10 and EW-20Olympus Corp. · 1995
  • K933200Olympus PBD StentsOlympus Corp. · 19954 recalls
  • K942338Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesOlympus Corp. · 1994
  • K931763HF-Resection Electrode, Loop W/Runner Endos/AccessOlympus Corp. · 1994
  • K934835FlovalOlympus Corp. · 1994

Recent decisions in FCC

The FCC category page

  • K843135Brimfield Cannulated Magnetic RetrieverBrimfield Scientific Instruments · 1984
  • K800971M.R. Assoc. Magnetic ExtractorMr Associates, Inc. · 1980

https://510kreport.com/device/K904668 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904668: IE Magnetic Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904668

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