510(k) Report

510(k) · Cleared

Cleared

Eye Surgery Instrument

K840101510(k) TraditionalCleared Mar 16, 198466-day reviewClass I21 CFR 886.4350

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

Truline Instruments, Inc. · HOB Clamp, Muscle, Ophthalmic

Cleared on Mar 16, 1984 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 16, 1984
Review
66 days
Class
Class I
Product code
HOB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K840101Source: 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 HOB devices

HOB Clamp, Muscle, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HOB

FDA has decided no HOB device since 2007.

Median 510(k) review, days · HOB

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

Recalls per year · HOB

No recall names HOB since 2007.

Adverse event reports per year · HOB

No MAUDE report names HOB 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 HOB

The HOB category page

  • K840310Category 6 Opthalmic DevicesImm Enterprises, Ltd. · 1984
  • K780851Charles Endocoagulator Accessory for ArcVarian Assoc., Inc. · 1978

https://510kreport.com/device/K840101 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840101: Eye Surgery Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840101

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