510(k) Report

510(k) · Cleared

Cleared

Ryder Lacrimal Intubationset

K962151510(k) TraditionalCleared Sep 18, 1996106-day reviewClass U

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

Ryder Intl. Corp. · OKS Lacrimal Stents And Intubation Sets

Cleared on Sep 18, 1996 after a 106-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided
Sep 18, 1996
Review
106 days
Class
Class U
Product code
OKS
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962151 Ryder Lacrimal IntubationsetRyder Intl. Corp. · 1996
  2. Descendant · cites it directly · 0 of its ownK113118 Stentube Lacrimal Intubation SetQuest Medical, Inc. · 2012
  3. Descendant · cites it directly · 0 of its ownK973633 Atrion Medical Products Lacrimal Intubation SetAtrion Medical Products, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K113118Stentube Lacrimal Intubation SetQuest Medical, Inc. · 2012 · cites it directly0descendants
  • K973633Atrion Medical Products Lacrimal Intubation SetAtrion Medical Products, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962151Ryder Lacrimal IntubationsetRyder Intl. Corp.1996—
+1K113118Stentube Lacrimal Intubation SetQuest Medical, Inc.2012—
+1K973633Atrion Medical Products Lacrimal Intubation SetAtrion Medical Products, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201210
FIG. 1 — Lineage of K962151, 1996–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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. #1 K201892 Ritleng®+ and Ritleng®+ PVPscore 1.0 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Concept 9035 Guibor Canaliculus Intubation Set
Named without a submission number
—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K113118Stentube Lacrimal Intubation SetQuest Medical, Inc.20120
K973633Atrion Medical Products Lacrimal Intubation SetAtrion Medical Products, Inc.19980

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?

  • Of its descendants, K113118 (Quest Medical, Inc., 2012) has gone furthest, with 0 descendants of its own.

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.

FDA decisions per year · OKS

1in 2021

2012: 72013: 22014: 12015: 12016: 22017: 12020: 12021: 1
2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OKS

277in 2012

2012: 277 days median
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

2011: 22012: 32013: 32014: 82015: 142016: 212017: 182018: 62019: 82020: 22021: 62022: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—02
2012727703
20132—03
20141—08
20151—014
20162—021
20171—018
20180—06
20190—08
20201—02
20211—06
20220—03
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Ryder Lacrimal Intubation set is valuable in the reconstruction of the lacrimal outflow system and also useful in canaliculus repair, lacrimal obstruction and complicated and uncomplicated dacryocystorhinostomy procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K962151: Ryder Lacrimal Intubationset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962151

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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