Spiro-VISTA— 510(k) K253437
Substantially EquivalentSpiro Robotics
FDA 510(k) clearance K253437 for Spiro-VISTA, Substantially Equivalent on 2026-06-12. Applicant: Spiro Robotics. Device class: 2.
Summary
Spiro Robotics' Spiro-VISTA is filed under BTR, tracheal tubes with or without a connector. The record doesn't describe the device beyond its name and the code name.
Class II, 21 CFR 868.5730. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Spiro Robotics filed from Hayward, California. Review took 254 calendar days (October 1, 2025 to June 12, 2026).
Clearance details
- Applicant
- Spiro Robotics
- Product code
- Product code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hayward, CA, US
Recent devices under product code BTR
view all- K251794 — Tenax® Laser Resistant Endotracheal Tube
- K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K243579 — AeroJet Ventilation Catheter
- K251499 — Frova Intubating Introducer (4 models)
Adverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.