510(k) · Cleared

Cleared

Lacrifast

K120886510(k) TraditionalCleared Dec 17, 2012269-day reviewClass U

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

Hiroyasu Higuchi · OKS Lacrimal Stents And Intubation Sets

Cleared on Dec 17, 2012 as substantially equivalent to K991238 (Fci Ophthalmics, Inc., 1999) and 1 other predicate after a 269-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.

Decided: Dec 17, 2012
Review: 269 days
Class: Class U
Product code: OKS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K991238 (1999). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK991238 Fci Crawford Probe Intubation SetsFci Ophthalmics, Inc. · 1999
This deviceK120886 LacrifastHiroyasu Higuchi · 2012
Descendant · cites it directly · 0 of its ownK170247 Lacriflow CLKaneka Pharma America, LLC · 2017
Descendant · cites it directly · 0 of its ownK161373 NunchakuFci (France Chirurgie Instrumentation) · 2016

Most influential descendants

Showing 2 of 2 · See all

K170247Lacriflow CLKaneka Pharma America, LLC · 2017 · cites it directly0descendants
K161373NunchakuFci (France Chirurgie Instrumentation) · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991238	Fci Crawford Probe Intubation Sets	Fci Ophthalmics, Inc.	1999	—
0 (this device)	K120886	Lacrifast	Hiroyasu Higuchi	2012	—
+1	K170247	Lacriflow CL	Kaneka Pharma America, LLC	2017	—
+1	K161373	Nunchaku	Fci (France Chirurgie Instrumentation)	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0

FIG. 1 — Lineage of K120886, 1999–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OKS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OKS device

#1 K201892 Ritleng®+ and Ritleng®+ PVPscore 1.0 · 1 generation · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K991238	Fci Crawford Probe Intubation Sets Summary page 2 …FAX:(212)705-4350_ f. Predicate devices The LACRIFAST is substantially equivalent to the following legally marketed devices: 5 10(k): K991238 Trade name: FCI CRAWFORD PROBE INTUBATION S&tS Product code: OKS 5 10(k): K0418…	Fci Ophthalmics, Inc.	1999	—
*	K041869	Self Retaining Bicanaliculus Intubation Set Summary page 2 …devices: 5 10(k): K991238 Trade name: FCI CRAWFORD PROBE INTUBATION S&tS Product code: OKS 5 10(k): K041869 Trade name: SELF RETAINING RICANALICULUS INIUBATION SET Product code: OKS g. Description of the d…	Fci Ophthalmics, Inc.	2004	—

Also cleared against K991238: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K170247	Lacriflow CL	Kaneka Pharma America, LLC	2017	0
K161373	Nunchaku	Fci (France Chirurgie Instrumentation)	2016	0

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.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K170247 (Kaneka Pharma America, LLC, 2017) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K991238.

How does its category compare?

All OKS devices

OKS Lacrimal Stents And Intubation Sets: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OKS

1in 2021

2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OKS

277in 2012

2007high 277 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OKS

No recall names OKS since 2007.

Adverse event reports per year · OKS

3in 2022

2007high 21 (2016) · low 0 (2007)2025

MAUDE reports naming product code OKS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	2
2012	7	277	3
2013	2	—	3
2014	1	—	8
2015	1	—	14
2016	2	—	21
2017	1	—	18
2018	0	—	6
2019	0	—	8
2020	1	—	2
2021	1	—	6
2022	0	—	3
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The LACRIFLOW is indicated in treatments of epiphora in patients 12 months and older, in cases of:

- Canalicular pathologies (stenosis, obstruction, lacerations),

- During Dacryocystorhinostomy (conventional or laser),

- Congenital nasolacrimal duct obstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120886 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120886: Lacrifast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120886

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026