510(k) · Cleared
ClearedDeroyal Industries, Inc. Surgical Eye Spear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · HOZ Sponge, Ophthalmic
Cleared on Sep 30, 1997 as substantially equivalent to K923922 (Ultracell Medical Technologies, Inc., 1993) after a 74-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Sep 30, 1997
- Review
- 74 days
- Class
- Class II
- Product code
- HOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923922 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK923922 Surgical SpearsUltracell Medical Technologies, Inc. · 1993 · Recalled
- This deviceK972693 Deroyal Industries, Inc. Surgical Eye SpearDeroyal Industries, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK130117 Network Eye Spears, Points, Drains, Wicks and ShieldsNetwork Medical Products, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130117Network Eye Spears, Points, Drains, Wicks and ShieldsNetwork Medical Products, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923922 | Surgical Spears | Ultracell Medical Technologies, Inc. | 1993 | 3 |
| 0 (this device) | K972693 | Deroyal Industries, Inc. Surgical Eye Spear | Deroyal Industries, Inc. | 1997 | — |
| +1 | K130117 | Network Eye Spears, Points, Drains, Wicks and Shields | Network Medical Products, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923922 | Surgical SpearsSummary page 1…Eye Spear COMMON/USUAL NAME: Eye Spear CLASSIFICATION NAME (if known): Sponge, Ophthalmic (86HOZ) PREDICATE OR LEGALLY MARKETED DEVICE Ultracell Medical Technologies (K923922) DEVICE DESCRIPTION The DeRoyal Industries, Inc., Surgical Eye Spear functions in the same manner as predicate devices in that i… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130117 | Network Eye Spears, Points, Drains, Wicks and Shields | 2013 | 0 |
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?
How does its category compare?
All HOZ devicesHOZ Sponge, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOZ
2in 2013
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HOZ
3in 2025
MAUDE reports naming product code HOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 3 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DeRoyal Industries Inc., Surgical Eye Spear is to be used to absorb fluids from the operative field during ophthalmic and microscopic surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972693: Deroyal Industries, Inc. Surgical Eye Spear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972693
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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