510(k) Report

510(k) · Cleared

Cleared

Nci Spatula

K110734510(k) TraditionalCleared May 31, 2012442-day reviewClass I21 CFR 886.4300

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

Fischer Surgical, Inc. · OTZ Graft Insertion Instrument For Endothelial Keratoplasty

Cleared on May 31, 2012 after a 442-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 31, 2012
Review
442 days
Class
Class I
Product code
OTZ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K110734Source: 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 OTZ? 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 OTZ device

  1. #1 K203586 EndoSerter-PLscore 3.1 · 2 generations · no Class I recall
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 OTZ devices

OTZ Graft Insertion Instrument For Endothelial Keratoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OTZ

1in 2022

2011: 22012: 22022: 1
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTZ

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

Recalls per year · OTZ

No recall names OTZ since 2007.

Adverse event reports per year · OTZ

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code OTZ, 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
20112—00
20122—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20221—00
20230—00
20240—01
20250—00
20260—0—

Recent decisions in OTZ

The OTZ category page

  • K203586EndoSerter-PLCorneagen, Inc. · 2022
  • K121579EK Delivery DeviceTdak Medical, Inc. · 2012
  • K102999Trimotion InjectorKaneka Corp. · 2011
  • K090626EndoserterOcular Systems, Inc. · 2011

https://510kreport.com/device/K110734 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110734: Nci Spatula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110734

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