510(k) · Cleared
ClearedModification to Laser-Shield II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jan 20, 2000 after a 90-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 20, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK993582 Modification to Laser-Shield IIXomed, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK200761 Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK213028 Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK251794 Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K200761Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2020 · cites it directly2descendants
- K213028Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2021 · 2 generations on1descendant
- K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993582 | Modification to Laser-Shield II | Xomed, Inc. | 2000 | — |
| +1 | K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2020 | — |
| +2 | K213028 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2021 | — |
| +3 | K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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.
Planning a device in BTR? 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 12.5 · 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? (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 |
|---|---|---|---|
| * | — | Laser-Shield II Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200761 | Tenax Laser Resistant Endotracheal Tube | 2020 | 2 |
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, K200761 (Bryan Medical, Inc., 2020) has gone furthest, with 2 descendants of its own.
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.
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?
Xomed Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993582: Modification to Laser-Shield II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993582
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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