VENTLAB VERIFY II— 510(k) K990098

Clearance details

Applicant

Ventlab Corp.

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

1999-01-12

Decision date

1999-02-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Crofton, MD, US

• K251794 — Tenax® Laser Resistant Endotracheal Tube2026-09-03
• K253437 — Spiro-VISTA2026-06-12
• 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)2025-10-06
• 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 Reinforced2025-09-25
• K243579 — AeroJet Ventilation Catheter2025-08-13

• K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER2012-05-24
• K102674 — CUFF SENTRY2011-07-22
• K093617 — VENTLAB 6000 SERIES HUMIDIFIER2011-01-27
• K093525 — ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE2009-12-10
• K090840 — VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.2009-06-25

Death

92

Injury

1,263

Malfunction

7,475

Other

2

Total

8,832

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →