510(k) Report

510(k) · Cleared

Cleared

Morgan Therapeutic Lens

K871454510(k) TraditionalCleared Jun 19, 198767-day reviewClass I21 CFR 886.4360

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

Mortan, Inc. · KYG Device, Irrigation, Ocular Surgery

Cleared on Jun 19, 1987 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 19, 1987
Review
67 days
Class
Class I
Product code
KYG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K871454Source: 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 KYG? 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
  • Recall history across each candidate’s familyin 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 KYG devices

KYG Device, Irrigation, Ocular Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYG

FDA has decided no KYG device since 2007.

Median 510(k) review, days · KYG

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

Recalls per year · KYG

1in 2023

2007: 42010: 22023: 1
2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KYG

72in 2025

2007: 1032008: 612009: 502010: 1272011: 812012: 3322013: 2422014: 2582015: 792016: 142017: 102018: 102019: 132020: 82021: 192022: 202023: 232024: 812025: 72
2007high 332 (2012) · low 8 (2020)2025

MAUDE reports naming product code KYG, 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—4103
20080—061
20090—050
20100—2127
20110—081
20120—0332
20130—0242
20140—0258
20150—079
20160—014
20170—010
20180—010
20190—013
20200—08
20210—019
20220—020
20230—123
20240—081
20250—072
20260—0—

More from Mortan, Inc.

2 FDA decisions under this applicant name. See the company

Recent decisions in KYG

The KYG category page

  • K010353Med-Logics Disposable Alk TubingMed-Logics, Inc. · 2001
  • K003036Turbo-Flow Infusion Cannula 19 Gage,20 Gage,23 Gage, 25 Gage, Model 101019,101020,101023,101025Retinalabs.Com · 2000
  • K993591Bladeworks Disposable Alk TubingBlade Works, Inc. · 1999
  • K981116Sovereign Cataract Extraction SystemAllergan, Inc. · 19981 recall
  • K980647Eye Irrigator Model #2020Eye-Deal Ocular Safety Products, Inc. · 1998

https://510kreport.com/device/K871454 · printed Nov 4, 2026

Cite this page

510(k) Report. “K871454: Morgan Therapeutic Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871454

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