510(k) Report

510(k) · Cleared

Cleared

Koi Lacremal Hook & Dilator

K812097510(k) TraditionalCleared Aug 18, 198125-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

Koi, Inc. · HNW Dilator, Lachrymal

Cleared on Aug 18, 1981 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 18, 1981
Review
25 days
Class
Class I
Product code
HNW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K812097Source: 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 HNW? 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
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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 HNW devices

HNW Dilator, Lachrymal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNW

FDA has decided no HNW device since 2007.

Median 510(k) review, days · HNW

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

Recalls per year · HNW

No recall names HNW since 2007.

Adverse event reports per year · HNW

9in 2024

2007: 22008: 32009: 22010: 62014: 12015: 12020: 32023: 22024: 9
2007high 9 (2024) · low 0 (2011)2025

MAUDE reports naming product code HNW, 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—02
20080—03
20090—02
20100—06
20110—00
20120—00
20130—00
20140—01
20150—01
20160—00
20170—00
20180—00
20190—00
20200—03
20210—00
20220—00
20230—02
20240—09
20250—00
20260—0—

More from Koi, Inc.

7 FDA decisions under this applicant name. See the company

  • K843247Koi PachymeterKoi, Inc. · 1986
  • K830366Diamond KnifeKoi, Inc. · 1983
  • K812764Koi Blue Field EntoptoscopeKoi, Inc. · 1981
  • K812450Koi Diamond KnifeKoi, Inc. · 1981
  • K812010Koi Lacrimal Intubation SystemKoi, Inc. · 1981

Recent decisions in HNW

The HNW category page

  • K862070Inter-SharpIntermedics Intraocular, Inc. · 1986
  • K841002Lachrymal Probes-VariousPremier Dental Products Co. · 1984

https://510kreport.com/device/K812097 · printed Nov 6, 2026

Cite this page

510(k) Report. “K812097: Koi Lacremal Hook & Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K812097

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