510(k) · Cleared
ClearedAbs Blower, Abs Nozzle, Model 1001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nimbic Systems, LLC · ORC Air Filter Portable Apparatus
Cleared on May 20, 2011 as substantially equivalent to K831531 (Lone Star Medical Products, Inc., 1984) after a 616-day review. Its family tree reaches back 1 generation to 1984. 4 later devices descend from it.
- Decided
- May 20, 2011
- Review
- 616 days
- Class
- Class II
- Product code
- ORC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831531 (1984). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK831531 Surgical Isolation Barrier SystemLone Star Medical Products, Inc. · 1984
- This deviceK092801 Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC · 2011
- Descendant · cites it directly · 3 of its ownK123006 Air Barrier System (Abs)Nimbic Systems, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK153498 OperioToul Meditech AB · 2016
- Descendant · 3 generations on · 0 of its ownK173349 OperioToul Meditech AB · 2017
- Descendant · 3 generations on · 0 of its ownK163455 SurgiCubeSurgicube International B.V. · 2017
Most influential descendants
Showing 4 of 4 · See all- K123006Air Barrier System (Abs)Nimbic Systems, Inc. · 2013 · cites it directly3descendants
- K153498OperioToul Meditech AB · 2016 · 2 generations on2descendants
- K173349OperioToul Meditech AB · 2017 · 3 generations on0descendants
- K163455SurgiCubeSurgicube International B.V. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831531 | Surgical Isolation Barrier System | Lone Star Medical Products, Inc. | 1984 | — |
| 0 (this device) | K092801 | Abs Blower, Abs Nozzle, Model 1001 | Nimbic Systems, LLC | 2011 | — |
| +1 | K123006 | Air Barrier System (Abs) | Nimbic Systems, Inc. | 2013 | — |
| +2 | K153498 | Operio | Toul Meditech AB | 2016 | — |
| +3 | K173349 | Operio | Toul Meditech AB | 2017 | — |
| +3 | K163455 | SurgiCube | Surgicube International B.V. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K831531 | Surgical Isolation Barrier SystemSummary page 1…d intended use features and performance of the ABS System issubstantially equivalent with regard to features and performance of 135 the predicate device, SIBS (K831531). Device Description: The Air Barrier System (ABS) is used in the surgical operating room. The Air Barrier System… | 1984 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123006 | Air Barrier System (Abs) | 2013 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K123006 (Nimbic Systems, Inc., 2013) has gone furthest, with 3 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. 2011, 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?
The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the nozzle and…
Read the full statement (134 words)
The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel to the direction of airflow, and (3) the incision dimensions are within: 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092801: Abs Blower, Abs Nozzle, Model 1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092801
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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