510(k) · Cleared
ClearedOperio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toul Meditech AB · ORC Air Filter Portable Apparatus
Cleared on Jul 20, 2016 as substantially equivalent to K123006 (Nimbic Systems, Inc., 2013) after a 226-day review. Its family tree reaches back 3 generations to 1984. 2 later devices descend from it.
- Decided
- Jul 20, 2016
- Review
- 226 days
- Class
- Class II
- Product code
- ORC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831531 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK831531 Surgical Isolation Barrier SystemLone Star Medical Products, Inc. · 1984
- 2 generations backK092801 Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC · 2011
- 1 generation backK123006 Air Barrier System (Abs)Nimbic Systems, Inc. · 2013
- This deviceK153498 OperioToul Meditech AB · 2016
- Descendant · cites it directly · 0 of its ownK173349 OperioToul Meditech AB · 2017
- Descendant · cites it directly · 0 of its ownK163455 SurgiCubeSurgicube International B.V. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831531 | Surgical Isolation Barrier System | Lone Star Medical Products, Inc. | 1984 | — |
| −2 | K092801 | Abs Blower, Abs Nozzle, Model 1001 | Nimbic Systems, LLC | 2011 | — |
| −1 | K123006 | Air Barrier System (Abs) | Nimbic Systems, Inc. | 2013 | — |
| 0 (this device) | K153498 | Operio | Toul Meditech AB | 2016 | — |
| +1 | K173349 | Operio | Toul Meditech AB | 2017 | — |
| +1 | K163455 | SurgiCube | Surgicube International B.V. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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 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 |
|---|---|---|---|
| * | K123006 | Air Barrier System (Abs)Summary page 4…B claims SE for. Code Manufacturer Device 510(k) # ORC Nimbic, Inc Air Barrier System K123006 K153498 Page 2 of 5 Device descri… | 2013 |
What descends from it? (2)
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 32 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173349 (Toul Meditech AB, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ORC devicesORC Air Filter Portable Apparatus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Operio is a portable device for use in a surgical operating room that produces 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 air flow is intended to be directed parallel to the…
Read the full statement (128 words)
Operio is a portable device for use in a surgical operating room that produces 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 air flow is intended to be directed parallel to the surgical site and/or instruments within: 20" (50 cm) in width, 47" (120 cm) in length and 15" (40 cm) in height. Device effectiveness may not be reliably detectable at a distance of 47 inches (120 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/K153498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153498: Operio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153498
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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