Product code BYF— Anesthesiology
2 JET SET
- Classification name
- Mask, Oxygen, Low Concentration, Venturi
- Device class
- Class 1
- Regulation
- 21 CFR 868.5600
- Advisory panel
- Anesthesiology
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code BYF
FDA has cleared devices under product code BYF between 1976 and 1996, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1995
- 1989
- 1986
- 1985
- 1983
- 1981
- 1979
- 1978
- 1977
- 1976
Top applicants under product code BYF
Recent clearances under product code BYF
- K955483 — TRACH MASK MODEL (245, 246)
- K951652 — VENTIMASK MK IV
- K894457 — CARNATION TRACHEOSTOMY MASKS
- K860873 — VENTURI MASK/ADULT & PAEDIATRIC
- K860874 — VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC
- K852618 — OXY-DIAL
- K832725 — DUAL DIAL VENTURI STYLE MASK
- K812066 — PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN
- K810946 — ADULT & PEDIATRIC TRACHEOSTOMY MASKS
- K810947 — AIR ENTRAINMENT TRACH T
- K810373 — VENTURI MASK/DELIVERY SYSTEM #'S
- K810430 — VENTURI MASK/DELIVERY SYSTEM #6078
- K790146 — MASK, PERCENTO
- K781325 — MARKII VENTIMASKS
- K780626 — VENTURI OXYGEN MASK
- K780011 — CONCHAPAK OXYGEN DILUTER
- K772127 — OXYGEN MASK, AIR-ENTRAINMENT
- K771385 — 2 JET SET
- K760518 — ADAPTER, PER-CEN-TOX-BODY
Data sourced from openFDA. This site is unofficial and independent of the FDA.