510(k) Report

510(k) · Cleared

Cleared

Network Eye Spears, Points, Drains, Wicks and Shields

K130117510(k) TraditionalCleared Oct 29, 2013286-day reviewClass II21 CFR 886.4790

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

Network Medical Products, Ltd. · HOZ Sponge, Ophthalmic

Cleared on Oct 29, 2013 as substantially equivalent to K920354 (Ultracell Medical Technologies, Inc., 1992) and 3 other predicates after a 286-day review. Its family tree reaches back 2 generations to 1993.

Decided
Oct 29, 2013
Review
286 days
Class
Class II
Product code
HOZ
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K923922 (1993). 4 ancestors in all, the oldest K920354 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1992: 1 other ancestorK923922 · Surgical Spears · Ultracell Medical Technologies, Inc. · 1993 · recalledK972693 · Deroyal Industries, Inc. Surgical Eye Spear · Deroyal Industries, Inc. · 1997199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors K972693 · Deroyal Industries, Inc. Surgical Eye Spear · Deroyal Industries, Inc. · 1997K923922 · Surgical Spears · Ultracell Medical Technologies, Inc. · 1993 · recalled0
  1. Root · 2 generations backK923922 Surgical SpearsUltracell Medical Technologies, Inc. · 1993 · Recalled
  2. 1 generation backK972693 Deroyal Industries, Inc. Surgical Eye SpearDeroyal Industries, Inc. · 1997
  3. This deviceK130117 Network Eye Spears, Points, Drains, Wicks and ShieldsNetwork Medical Products, Ltd. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K923922Surgical SpearsUltracell Medical Technologies, Inc.19933
−1K972693Deroyal Industries, Inc. Surgical Eye SpearDeroyal Industries, Inc.1997—
0 (this device)K130117Network Eye Spears, Points, Drains, Wicks and ShieldsNetwork Medical Products, Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199910
FIG. 1 — Lineage of K130117, 1993–2013Source: 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 HOZ? 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? (4)

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
*K920354Ophthalmic Sponges
Summary page 1
…, Wicks and Shields Classification: Class 11 Regulation Number: 886.4790 Product Code: HOZ Predicate Devices: Ultracell Medical Technologies. Inc., Ophthalmic Sponges, K920354 Ultracell Medical Technologies, Inc., Surgical Spears, K923922 DeRoyal Industries, Inc., Surgical Eye Spears, K972693 Hurri…
Ultracell Medical Technologies, Inc.19921
*K923922Surgical Spears
Summary page 1
…86.4790 Product Code: HOZ Predicate Devices: Ultracell Medical Technologies. Inc., Ophthalmic Sponges, K920354 Ultracell Medical Technologies, Inc., Surgical Spears, K923922 DeRoyal Industries, Inc., Surgical Eye Spears, K972693 Hurricane Medical, Inc., Drainage Wick; Surgical Spears and Sponges. C…
Ultracell Medical Technologies, Inc.19933
*K972693Deroyal Industries, Inc. Surgical Eye Spear
Summary page 1
…Medical Technologies. Inc., Ophthalmic Sponges, K920354 Ultracell Medical Technologies, Inc., Surgical Spears, K923922 DeRoyal Industries, Inc., Surgical Eye Spears, K972693 Hurricane Medical, Inc., Drainage Wick; Surgical Spears and Sponges. Corneal Light Shield, K990671 Indication for Use…
Deroyal Industries, Inc.1997—
*K990671Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument Wipe
Summary page 1
…s, K923922 DeRoyal Industries, Inc., Surgical Eye Spears, K972693 Hurricane Medical, Inc., Drainage Wick; Surgical Spears and Sponges. Corneal Light Shield, K990671 Indication for Use: Eve Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and…
Hurricane Medical1999—

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.

What does this lineage say?

  • The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
  • 2 of the 4 ancestors have a recall of any class.

How does its category compare?

All HOZ devices

HOZ Sponge, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HOZ

2in 2013

2008: 12009: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HOZ

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

Recalls per year · HOZ

3in 2024

2013: 12022: 12024: 3
2007high 3 (2024) · low 0 (2007)2026

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

Adverse event reports per year · HOZ

3in 2025

2007: 12008: 22009: 22010: 12013: 22015: 12016: 22019: 12020: 22021: 12023: 62024: 32025: 3
2007high 6 (2023) · low 0 (2011)2025

MAUDE reports naming product code HOZ, 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—01
20081—02
20091—02
20100—01
20110—00
20120—00
20132—12
20140—00
20150—01
20160—02
20170—00
20180—00
20190—01
20200—02
20210—01
20220—10
20230—06
20240—33
20250—03
20260—0—

What is it indicated for?

Network Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field.

Network Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field.

Network Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.

Indications for use as stated in the FDA summary.

Recent decisions in HOZ

The HOZ category page

  • K132796Suntouch Eye SpearHuizhou Foryou Medical Devices Co., Ltd. · 2013
  • K091240Alphamed Surgical Spear, Model 70-5000Alphamed, Inc. · 2009
  • K082460Cenefom Pva Surgical SpearLongtek Scientific Co., Ltd. · 2008
  • K012196Ultracell Absorbent StickUltracell Medical Technologies, Inc. · 2001
  • K011191Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic SpongesMedtronic Xomed, Inc. · 2001

https://510kreport.com/device/K130117 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130117: Network Eye Spears, Points, Drains, Wicks and Shields.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130117

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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