510(k) Report

510(k) · Cleared

Cleared

Retinal Taak

K901275510(k) TraditionalCleared Mar 23, 19904-day reviewClass II21 CFR 886.3100

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

Alcon Surgical, Inc. · HQW Clip, Tantalum, Ophthalmic

Cleared on Mar 23, 1990 after a 4-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 23, 1990
Review
4 days
Class
Class II
Product code
HQW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K901275Source: 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 HQW? 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 HQW devices

HQW Clip, Tantalum, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQW

FDA has decided no HQW device since 2007.

Median 510(k) review, days · HQW

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

Recalls per year · HQW

No recall names HQW since 2007.

Adverse event reports per year · HQW

2in 2021

2020: 22021: 2
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code HQW, 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—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—02
20210—02
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Alcon Surgical, Inc.

3 FDA decisions under this applicant name. See the company

  • K902798Automated Hydrosonics (TM)Alcon Surgical, Inc. · 1990
  • K897099Model 2800 ND:Yag Ophthalmic LaserAlcon Surgical, Inc. · 1990

Recent decisions in HQW

The HQW category page

  • K897119Grieshaber Retinal Tack and Sutherland Tack ForcepGrieshaber & Co. · 1990
  • K840207Double & Single Tantalum ClipsStorz Instrument Co. · 1984

https://510kreport.com/device/K901275 · printed Nov 4, 2026

Cite this page

510(k) Report. “K901275: Retinal Taak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K901275

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