510(k) · Decided
DecidedOasis Lacrimal Intubation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anodyne · OKS Lacrimal Stents And Intubation Sets
Cleared on May 13, 2016 as substantially equivalent to K121142 (Fci Sas (France Chirurgie Instrumentation), 2012) after a 59-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- May 13, 2016
- Review
- 59 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991238 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991238 | Fci Crawford Probe Intubation Sets | Fci Ophthalmics, Inc. | 1999 | — |
| −1 | K121142 | Crawford Biocanaliculus Intubation | Fci Sas (France Chirurgie Instrumentation) | 2012 | — |
| 0 (this device) | K160710 | Oasis Lacrimal Intubation Set | Anodyne | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K121142 | Crawford Biocanaliculus IntubationSummary page 4…Product Code: OKS FDA Panel: Ophthalmic Predicate Device: Sold separately - FCI, Crawford Bicanaliculus Intubation (Unclassified - K121142 - Product Code OKS) and Crawford Hook (Class 1 - 510(K) Exempt - Product Code HNQ – Reg. Number… | 2012 |
| * | — | Crawford Hook Named without a submission number |
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.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K121142.
How does its category compare?
All OKS devicesOKS Lacrimal Stents And Intubation Sets: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OKS
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OKS
277in 2012
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 7 | 277 | 0 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients 12 months of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are:
Canalicular pathologies (e.g.. congenital or acquired stenosis. lacerations)
During dacryocystorhinostomy
Congenital lacrimal duct obstruction
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160710 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160710: Oasis Lacrimal Intubation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160710
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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