510(k) · Cleared
ClearedStephens Disposable Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stephens Instruments · HNR Forceps, Ophthalmic
Cleared on Nov 1, 2002 after a 66-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 1, 2002
- Review
- 66 days
- Class
- Class I
- Product code
- HNR
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HNR? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Katena Ophthalmic Forceps Named without a submission number | |
| * | — | Storz Ophthalmic Forceps Named without a submission number | |
| * | — | Rhein Ophthalmic Forceps Named without a submission number | |
| * | — | Stephens Ophthalmic Forceps Named without a submission number |
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 HNR devicesHNR Forceps, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNR
FDA has decided no HNR device since 2007.
Median 510(k) review, days · HNR
Too few HNR 510(k)s in any year since 2007 to give a median.
Recalls per year · HNR
12so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNR
115in 2025
MAUDE reports naming product code HNR, 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 | 3 |
| 2008 | 0 | — | 2 | 4 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 21 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 39 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 135 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 0 | 58 |
| 2023 | 0 | — | 1 | 98 |
| 2024 | 0 | — | 0 | 81 |
| 2025 | 0 | — | 0 | 115 |
| 2026 | 0 | — | 12 | — |
What is it indicated for?
Forceps for single use designed for the manipulation of tissue or muscles in various ophthalmic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022835: Stephens Disposable Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022835
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026