# K082038: Clarus Video Airway Endoscope, Models 30000-V and 30003-V

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: Apr 28, 2009 after 285 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921244 (1992). 24 ancestors in all.
No later device cites it as a predicate yet.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor, Vision-Sciences, Inc. (2007) Summary page 1.
- K071530: Karl Storz Video Flexible Video Ent Endoscope System, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 1.
- K962255: Clarus Murphypen Endoscope (2127-XXX), Clarus Medical Systems, Inc. (1996) Summary page 1.
- K052233: Tracheoscopic Ventilation Tube (TVT) System, Etview, Ltd. (2005) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K082038
Methodology: https://510kreport.com/methodology