510(k) Report

510(k) · Cleared

Cleared

H200 Hanna Suction Trephine System for Corneal Sur

K896473510(k) TraditionalCleared Feb 9, 199088-day reviewClass I21 CFR 886.4445

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

Emory University School of Medicine · HPN Magnet, Permanent

Cleared on Feb 9, 1990 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 9, 1990
Review
88 days
Class
Class I
Product code
HPN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K896473Source: 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 HPN devices

HPN Magnet, Permanent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPN

FDA has decided no HPN device since 2007.

Median 510(k) review, days · HPN

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

Recalls per year · HPN

No recall names HPN since 2007.

Adverse event reports per year · HPN

No MAUDE report names HPN 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—

Recent decisions in HPN

The HPN category page

  • K905237Eye See InstrumentKing Tool, Inc. · 1991
  • K880855Parel Rare Earth Magnet, I.O.M., Intraocular MagRichard James, Inc. · 1988
  • K860960Rare Earth Intra-Ocular MagnetAmeritek, Inc. · 1986
  • K831702Rare-Earth Intra-Ocular MagnetMiami Eye Technology, Inc. · 1983

https://510kreport.com/device/K896473 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896473: H200 Hanna Suction Trephine System for Corneal Sur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896473

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