510(k) · Cleared
ClearedSurgical Isolation Barrier System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lone Star Medical Products, Inc.
Cleared on Jun 5, 1984 after a 391-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 5, 1984
- Review
- 391 days
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK831531 Surgical Isolation Barrier SystemLone Star Medical Products, Inc. · 1984
- Descendant · cites it directly · 4 of its ownK092801 Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC · 2011
- Descendant · 2 generations on · 3 of its ownK123006 Air Barrier System (Abs)Nimbic Systems, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK153498 OperioToul Meditech AB · 2016
- Descendant · 4 generations on · 0 of its ownK173349 OperioToul Meditech AB · 2017
- Descendant · 4 generations on · 0 of its ownK163455 SurgiCubeSurgicube International B.V. · 2017
Most influential descendants
Showing 5 of 5 · See all- K092801Abs Blower, Abs Nozzle, Model 1001Nimbic Systems, LLC · 2011 · cites it directly4descendants
- K123006Air Barrier System (Abs)Nimbic Systems, Inc. · 2013 · 2 generations on3descendants
- K153498OperioToul Meditech AB · 2016 · 3 generations on2descendants
- K173349OperioToul Meditech AB · 2017 · 4 generations on0descendants
- K163455SurgiCubeSurgicube International B.V. · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831531 | Surgical Isolation Barrier System | Lone Star Medical Products, Inc. | 1984 | — |
| +1 | K092801 | Abs Blower, Abs Nozzle, Model 1001 | Nimbic Systems, LLC | 2011 | — |
| +2 | K123006 | Air Barrier System (Abs) | Nimbic Systems, Inc. | 2013 | — |
| +3 | K153498 | Operio | Toul Meditech AB | 2016 | — |
| +4 | K173349 | Operio | Toul Meditech AB | 2017 | — |
| +4 | K163455 | SurgiCube | Surgicube International B.V. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in this category? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092801 | Abs Blower, Abs Nozzle, Model 1001 | 2011 | 4 |
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?
- Of its descendants, K092801 (Nimbic Systems, LLC, 2011) has gone furthest, with 4 descendants of its own.
https://510kreport.com/device/K831531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K831531: Surgical Isolation Barrier System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831531
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026