510(k) · Cleared
ClearedSolidAIRity III Airway Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Securisyn Medical, LLC · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Oct 9, 2019 as substantially equivalent to K111401 (Hangzhou Bever Medical Devices Co., Ltd., 2012) and 1 other predicate after a 211-day review. Its family tree reaches back 4 generations to 1996. 4 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 9, 2019
- Review
- 211 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961837 (1996). 8 ancestors in all, the oldest K843790 (1985). No later device cites it as a predicate yet. 4 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · Recalled (Class I)
- 3 generations backK993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed…Rusch Intl. · 2000 · Recalled (Class I)
- 2 generations backK042683 Well Lead Endotracheal TubeWell Lead Medical Instruments · 2005 · Recalled
- 1 generation backK111401 Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012
- This deviceK190630 SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC · 2019
Class I recalls in this family
- K993786 Rusch Oral/Nasal (Safety Clear Plus) Tracheal…3 generations back · 2000
- K961837 Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy3 generations back · 1996
- K961840 Rusch Oral/Nasal Tracheal Tube, Plain…3 generations back · 1996
- K931163 Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye3 generations back · 1993
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961837 | Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy | Rusch Intl. | 1996 | Class I |
| −3 | K993786 | Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy | Rusch Intl. | 2000 | Class I |
| −2 | K042683 | Well Lead Endotracheal Tube | Well Lead Medical Instruments | 2005 | 1 |
| −1 | K111401 | Bever Endotracheal Tube, Bever Eva Endotracheal Tube | Hangzhou Bever Medical Devices Co., Ltd. | 2012 | — |
| 0 (this device) | K190630 | SolidAIRity III Airway Stabilization System | Securisyn Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 1 |
| 1996 | 1 | 1 |
| 1997 | 1 | 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.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111401 | Bever Endotracheal Tube, Bever Eva Endotracheal TubeSummary page 4…BTR Regulation Number: 21 CFR 868.5730 Class: II Panel: Anesthesiology Predicate Devices: BEVER Endotracheal Tube and BEVER Eva Endotracheal Tube (K111401, Primary Predicate) Laerdal Thomas ET Tube Holder (K843790, Secondary Predicate) Device Description: The SolidAIRity III Airway… | 2012 |
| * | K843790 | Tracheal Tube Fixation DeviceSummary page 4…: II Panel: Anesthesiology Predicate Devices: BEVER Endotracheal Tube and BEVER Eva Endotracheal Tube (K111401, Primary Predicate) Laerdal Thomas ET Tube Holder (K843790, Secondary Predicate) Device Description: The SolidAIRity III Airway Stabilization System consists of: • Two (2) types of O… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993786Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/MurphyRusch Intl. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K961837Rush Oral/Nasal Tracheal Tube Cuffed Magill/MurphyRusch Intl. · 1996 · 3 generations back · ◆ on the line of descent in FIG. 132 Class I recalls
- K961840Rusch Oral/Nasal Tracheal Tube, Plain Magill/MurphyRusch Intl. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 124 Class I recalls
- K931163Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur EyeRusch, Inc. · 1993 · 3 generations back · ◆ in the 1993 ancestors bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 5 of the 8 ancestors have a recall of any class; 4 have a Class I recall.
- 2 other devices also cite its predicate K111401.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The SolidAIRity III Endotracheal Standard Tube is indicated for airway management of patients requiring oral intubation.
The SolidAIRity III Endotracheal Suction Tube is indicated for airway management of patients requiring oral intubation and for evacuation and drainage of subglottic secretions that accumulate above the cuff.
The SolidAIRity III Endotracheal Tube Stabilizer is indicated for airway management of patients by securing a SolidAIRity III Endotracheal Tube during oral intubation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190630: SolidAIRity III Airway Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190630
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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