510(k) · Cleared
ClearedSurgiCube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicube International B.V. · ORC Air Filter Portable Apparatus
Cleared on Sep 28, 2017 as substantially equivalent to K153498 (Toul Meditech AB, 2016) after a 293-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Sep 28, 2017
- Review
- 293 days
- Class
- Class II
- Product code
- ORC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K831531 (1984). No later device cites it as a predicate yet.
- Root · 4 generations backK831531 Surgical Isolation Barrier SystemLone Star Medical Products, Inc. · 1984
- 3 generations backK092801 Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC · 2011
- 2 generations backK123006 Air Barrier System (Abs)Nimbic Systems, Inc. · 2013
- 1 generation backK153498 OperioToul Meditech AB · 2016
- This deviceK163455 SurgiCubeSurgicube International B.V. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831531 | Surgical Isolation Barrier System | Lone Star Medical Products, Inc. | 1984 | — |
| −3 | K092801 | Abs Blower, Abs Nozzle, Model 1001 | Nimbic Systems, LLC | 2011 | — |
| −2 | K123006 | Air Barrier System (Abs) | Nimbic Systems, Inc. | 2013 | — |
| −1 | K153498 | Operio | Toul Meditech AB | 2016 | — |
| 0 (this device) | K163455 | SurgiCube | Surgicube International B.V. | 2017 | — |
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 ORC? 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 |
|---|---|---|---|
| * | K153498 | OperioSummary page 4…21 CFR 878.5070 Product code ORC Predicate device The legally marketed device to which substantial equivalence is claimed is: Operio K153498 Cleared 07/20/2016 K163455 Page 1 of 5… | 2016 |
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 33 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K153498.
How does its category compare?
All ORC devicesORC Air Filter Portable Apparatus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · ORC
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ORC
Too few ORC 510(k)s in any year since 2007 to give a median.
Recalls per year · ORC
No recall names ORC since 2007.
Adverse event reports per year · ORC
No MAUDE report names ORC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SurgiCube® is a stand-alone device that creates a surgical operating environment with a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of < 5 CFU per m3 at the surgical site and instruments. The surgical site of the patient is intended to…
Read the full statement (124 words)
SurgiCube® is a stand-alone device that creates a surgical operating environment with a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of < 5 CFU per m3 at the surgical site and instruments.
The surgical site of the patient is intended to be placed under the air flow which is directed downwards to the surgical site and/or instruments within 32" (80 cm) in length. Device effectiveness may not be reliably detectable at a distance of 32" (80 cm) from the air flow outlet, and effectiveness depreciates beyond this specified area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163455 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163455: SurgiCube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163455
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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