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 Dec 20, 2017 as substantially equivalent to K153498 (Toul Meditech AB, 2016) after a 56-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Dec 20, 2017
- Review
- 56 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 deviceK173349 OperioToul Meditech AB · 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) | K173349 | Operio | Toul Meditech AB | 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…ch AB claims SE for. Code Manufacturer Device 510(k) # ORC Toul Meditech AB Operio K153498 Page 2 of 5 Device descr… | 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 4 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?
Operio is a portable device for use in a surgical operating environment that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic, orthopedic and neuro 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…
Read the full statement (131 words)
Operio is a portable device for use in a surgical operating environment that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic, orthopedic and neuro 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/K173349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173349: Operio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173349
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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