510(k) · Cleared
ClearedOrbit Subretinal Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orbit Biomedical · FMF Syringe, Piston
Cleared on Jul 14, 2020 as substantially equivalent to K182274 (Orbit Biomedical, Inc., 2018) after a 155-day review. Its family tree reaches back 3 generations to 1998. 3 later devices descend from it.
- Decided
- Jul 14, 2020
- Review
- 155 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980069 (1998). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- 2 generations backK023752 BD Integra SyringeBd · 2003 · Recalled
- 1 generation backK182274 Orbit Subretinal Delivery SystemOrbit Biomedical, Inc. · 2018
- This deviceK200325 Orbit Subretinal Delivery SystemOrbit Biomedical · 2020
- Descendant · cites it directly · 2 of its ownK203264 MicroDose InjectorMedone Surgical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK250501 System SophiThis AG · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| −2 | K023752 | BD Integra Syringe | Bd | 2003 | 2 |
| −1 | K182274 | Orbit Subretinal Delivery System | Orbit Biomedical, Inc. | 2018 | — |
| 0 (this device) | K200325 | Orbit Subretinal Delivery System | Orbit Biomedical | 2020 | — |
| +1 | K203264 | MicroDose Injector | Medone Surgical, Inc. | 2021 | — |
| +1 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
| +2 | K250501 | System Sophi | This AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K182274 | Orbit Subretinal Delivery SystemSummary page 4…CT CODE: HMX, Ophthalmic Cannula Class I 21 CFR 886.4350 PREDICATE DEVICE: K182274 Orbit Subretinal Delivery System FMF, Syringe, Piston… | 2018 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K203264 (Medone Surgical, Inc., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200325: Orbit Subretinal Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200325
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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