510(k) · Cleared
ClearedClarus Video Airway Endoscope, Models 30000-V and 30003-V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarus Medical, LLC · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Apr 28, 2009 as substantially equivalent to K072073 (Vision-Sciences, Inc., 2007) and 3 other predicates after a 285-day review. Its family tree reaches back 6 generations to 1992. 1 of the 25 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 28, 2009
- Review
- 285 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K921244 (1992). 24 ancestors in all, the oldest K822082 (1982). No later device cites it as a predicate yet. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 2 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 1 generation backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- This deviceK082038 Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009
Class I recalls in this family
- K822082 Sheridan/HVT,CF, Uncuffed3 generations back · 1982
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −5 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −4 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −3 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −2 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −1 | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| 0 (this device) | K082038 | Clarus Video Airway Endoscope, Models 30000-V and 30003-V | Clarus Medical, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 1 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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.
1 device in this family has 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 12.5 · 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? (4)
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 |
|---|---|---|---|
| * | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Summary page 1…FAX (763) 525-8656 Email: tbarthel~clarus-medical.com Predicate Devices Vision-Sciences ENT-5000 and ENT-5 100 Video ENT S (K072073)) Karl Storz Video Bronchoscope System (K07 1530) Clamus 2127 Murphy Pen (K962255) ETVIEW Tracheoscopic Vent… | 2007 |
| * | K071530 | Karl Storz Video Flexible Video Ent Endoscope SystemSummary page 1…Email: tbarthel~clarus-medical.com Predicate Devices Vision-Sciences ENT-5000 and ENT-5 100 Video ENT S (K072073)) Karl Storz Video Bronchoscope System (K07 1530) Clamus 2127 Murphy Pen (K962255) ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233 Date Prepared… | 2007 |
| * | K962255 | Clarus Murphypen Endoscope (2127-XXX)Summary page 1…icate Devices Vision-Sciences ENT-5000 and ENT-5 100 Video ENT S (K072073)) Karl Storz Video Bronchoscope System (K07 1530) Clamus 2127 Murphy Pen (K962255) ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233 Date Prepared June 26, 2008 Device Description… | 1996 |
| * | K052233 | Tracheoscopic Ventilation Tube (TVT) SystemSummary page 1…NT S (K072073)) Karl Storz Video Bronchoscope System (K07 1530) Clamus 2127 Murphy Pen (K962255) ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233 Date Prepared June 26, 2008 Device Description The Model 30000-V endoscope is a tubular device with a mall… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K822082Sheridan/HVT,CF, UncuffedSheridan Catheter Corp. · 1982 · 3 generations back · ◆ in the 1982 ancestors bar of FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K072073.
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. 2009, 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 Clams Model 30000-V Video Endoscope is indicated for visualization of airway anatomy to aid in the placing and confirming placement of artificial airways.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082038: Clarus Video Airway Endoscope, Models 30000-V and 30003-V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082038
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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