510(k) Report

510(k) · Cleared

Cleared

Examiner 10

K781698510(k) TraditionalCleared Nov 3, 197824-day reviewClass II21 CFR 878.4580

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

American Sterilizer Co. · HJE Lamp, Fluorescein, Ac-Powered

Cleared on Nov 3, 1978 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 3, 1978
Review
24 days
Class
Class II
Product code
HJE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K781698Source: 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 HJE? 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 HJE devices

HJE Lamp, Fluorescein, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJE

FDA has decided no HJE device since 2007.

Median 510(k) review, days · HJE

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

Recalls per year · HJE

No recall names HJE since 2007.

Adverse event reports per year · HJE

No MAUDE report names HJE 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 American Sterilizer Co.

36 FDA decisions under this applicant name. See the company

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  • K931872The Eagle 3017 100% Ethylene Oxide SterilizerAmerican Sterilizer Co. · 1994
  • K922485Chemdi-VHP Chemical IndicatorAmerican Sterilizer Co. · 1993
  • K930493Quantum 3080 Surgical TableAmerican Sterilizer Co. · 1993
  • K905816Orthovision TableAmerican Sterilizer Co. · 1991

Recent decisions in HJE

The HJE category page

  • K922348Valtrac (R) Introducer ForcepAmerican Cyanamid Co. · 1992
  • K802291Fluorescent Sun Lamp FixtureStrato-Ray Co. · 1980

https://510kreport.com/device/K781698 · printed Nov 4, 2026

Cite this page

510(k) Report. “K781698: Examiner 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K781698

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