510(k) Report

510(k) · Cleared

Cleared

Malis Surgical Loupes

K874845510(k) TraditionalCleared Dec 23, 198729-day reviewClass I21 CFR 886.5120

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

Valley Forge Scientific Corp. · HJH Loupe, Binocular, Low Power

Cleared on Dec 23, 1987 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 23, 1987
Review
29 days
Class
Class I
Product code
HJH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K874845Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 HJH? 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
Get a 510(k) Report

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 HJH devices

HJH Loupe, Binocular, Low Power: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJH

FDA has decided no HJH device since 2007.

Median 510(k) review, days · HJH

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

Recalls per year · HJH

No recall names HJH since 2007.

Adverse event reports per year · HJH

2in 2022

2019: 22022: 2
2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code HJH, 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—00
20170—00
20180—00
20190—02
20200—00
20210—00
20220—02
20230—00
20240—00
20250—00
20260—0—

More from Valley Forge Scientific Corp.

27 FDA decisions under this applicant name. See the company

  • K050364Malis 2000 Bipolar Electrosurgical SystemValley Forge Scientific Corp. · 2005
  • K042604Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical InstrumentsValley Forge Scientific Corp. · 2004
  • K032601Stryker Interventional Pain RF GeneratorValley Forge Scientific Corp. · 20041 recall
  • K033499Malis Irrigation Module 1000Valley Forge Scientific Corp. · 2003
  • K982229BI-DentValley Forge Scientific Corp. · 1998

Recent decisions in HJH

The HJH category page

  • K863983Exeter Operating LoupeExeter Instruments, Inc. · 1986
  • K830878Binocular LoupeAlmore Intl., Inc. · 1983

https://510kreport.com/device/K874845 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874845: Malis Surgical Loupes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874845

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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