510(k) Report

510(k) · Cleared

Cleared

Scientronics 10K Eye Magnet

K832950510(k) TraditionalCleared Oct 19, 198349-day reviewClass II21 CFR 886.4440

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

Scientific Manufacturer · HPO Magnet, Ac-Powered

Cleared on Oct 19, 1983 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 19, 1983
Review
49 days
Class
Class II
Product code
HPO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K832950Source: 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 HPO devices

HPO Magnet, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPO

FDA has decided no HPO device since 2007.

Median 510(k) review, days · HPO

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

Recalls per year · HPO

No recall names HPO since 2007.

Adverse event reports per year · HPO

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code HPO, 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—01
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—
Cite this page

510(k) Report. “K832950: Scientronics 10K Eye Magnet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832950

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