510(k) Report

510(k) · Cleared

Cleared

Absorbable Intracanalicular Collagen Implant

K850649510(k) TraditionalCleared May 21, 198591-day review

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

Lacrimedics, Inc.

Cleared on May 21, 1985 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 21, 1985
Review
91 days
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared1990200020102020
  1. This deviceK850649 Absorbable Intracanalicular Collagen ImplantLacrimedics, Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK053333 Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K850649Absorbable Intracanalicular Collagen ImplantLacrimedics, Inc.1985—
+1K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K850649, 1985–2006Source: 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), 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc.20060

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, K053333 (Eagle Vision, Inc., 2006) has gone furthest, with 0 descendants of its own.

More from Lacrimedics, Inc.

12 FDA decisions under this applicant name. See the company

  • K161673LacriPro Punctum PlugLacrimedics, Inc. · 2016
  • K140026Collasyn Plug for the Lacrimal Efficiency TestLacrimedics, Inc. · 20141 recall
  • K030300Opaque Herrick Lacrimal PlugLacrimedics, Inc. · 2003
  • K021831Opaque Herrick Lacrimal Plug, 0.3MM,0.5MM,0.7MM, Models HLP3-Opb,HLP50OPB,HLP7-OpbLacrimedics, Inc. · 20021 recall
  • K001737Opaque Herrick Plug, 0.3MM; 0.5MM; O.7MMLacrimedics, Inc. · 2000

https://510kreport.com/device/K850649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850649: Absorbable Intracanalicular Collagen Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850649

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