Product code BZO— Anesthesiology
RAIN-X
- Classification name
- Set, Tubing And Support, Ventilator (W Harness)
- Device class
- Class 1
- Regulation
- 21 CFR 868.5975
- Advisory panel
- Anesthesiology
- Total cleared
- 88
- First cleared
- Most recent
Market context for product code BZO
FDA has cleared devices under product code BZO between 1976 and 1995, filed by 59 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
last 15 years- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
Top applicants under product code BZO
Recent clearances under product code BZO
- K953784 — UNICOR, INC. CORRUGATED TUBING
- K953785 — UNICOR, INC. VENTILATOR HOSES
- K952010 — PRIMA VENTILATOR HOSES
- K952011 — PRIMA BREATHING BAGS
- K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT
- K952022 — PRIMA VOLUMN VENTILATORSS
- K945740 — INFANT FLOW SYSTEM
- K944531 — PRIMA, INC. CORRUGATED TUBING
- K942569 — VENTILATOR HOSE
- K942572 — VOLUME VENTILATOR
- K935582 — TUBE, INHALER OXYGEN
- K934753 — STAR BREATHING CIRCUITS
- K932706 — PRECISION MED PRODUCTS LTD. VENTILATOR HOSE
- K932560 — VOLUME VENTILATORS
- K932712 — PRECISION MED PRODUCTS LTD VOLUME VENTILATORS
- K932563 — VENTILATOR HOSES
- K932119 — CLEVELAND TUBING, INC. VENTILATOR HOSES
- K922479 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
- K921510 — GAS SAMPLING KIT MODIFICATION
- K911328 — UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
- K903083 — NEONATAL VENTILATOR CIRCUIT
- K903055 — EXTENDED LIFE CIRCUITS
- K903404 — FLOCARE F
- K896439 — TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
- K895853 — SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
- K893760 — CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
- K890822 — CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
- K890011 — OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
- K884525 — PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
- K882341 — QUICK CONNECT T ADAPTOR
- K880959 — LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY
- K880637 — BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
- K874559 — BABYFLEX PATIENT CIRCUIT
- K873900 — PORTABLE VENTILATOR PATIENT CIRCUIT
- K873927 — REUSEABLE BREATHING TUBES
- K863756 — MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT
- K863910 — RAINCOAT
- K863033 — PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
- K860659 — END TIDAL CO2 SAMPLING CIRCUIT
- K861286 — GAS SAMPLING KIT
- K860879 — DISPOSABLE VENTILATOR CIRCUITS
- K860880 — VENTILATOR CIRCUITS (VARIOUS TYPES)
- K850151 — L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
- K850600 — CO-AX VENTILATOR CIRCUIT
- K850703 — SAF T FLO VENTILATOR TUBING
- K844290 — L100D PATIENT CIRCUIT DUAL LINE
- K843036 — PATIENT BREATHING CIRCUIT
- K842778 — AVATRON UNIVERSAL ADULT VOL. VENTILATOR
- K842389 — AVATRON DISPOSABLE I.P.P.B. CIRUCIT
- K841657 — PATIENT TUBING HYTREL SIEMENS-ELEMA
- K841722 — MASS SPECTROMETER INTERFACE
- K841378 — VENT-WELL VENTILATOR TUBING
- K841637 — THREE PORT SENSOR MANIFOLD
- K834569 — VENTILATORY FREQUENCY MONITOR
- K834570 — VOLUME VENTILATOR CIRCUIT W/WATER TRAP
- K833459 — COAXIAL VOL. VENTILATOR CIRCUIT
- K832681 — UNIVERSAL VOL. VENTILATOR 72 #1626
- K830923 — TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA
- K830921 — TEMP-CHECK ADAPTOR, Y-CONFIGURATION
- K830922 — TEMP-CHECK ADAPTOR, TEE-CONFIGURATION
- K823271 — DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
- K823481 — BE #16 - MANIFOLD
- K823479 — MODUFLEX NEONATAL VENTILATOR SET
- K823287 — RESPIRATORY CIRCUIT ADAPTOR
- K821064 — INSPIRON NEONATAL VENTILATOR CIRCUIT
- K820128 — UNI-SET
- K820131 — 3M VOLUME VENTIATOR CIRCUIT
- K813384 — DISPOSABLE NEONATAL VENTILATION CIRCUIT
- K813155 — PEDIATRIC VENTILATOR CIRCUIT 2C7131
- K812737 — RAIN-X
- K812773 — BENNETT VOLUME VENTILATOR CIRCUIT
- K812774 — VENTILATOR CIRCUIT
- K810341 — LIFELINE IPPB SET-UP
- K801859 — CAM-10 RESPIRATORY HOSE ASSEMBLIES
- K801087 — NEONATAL BREATHING CIRCUIT SYSTEM
- K792268 — CIRCAPAK
- K792030 — TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT
- K792047 — CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,
- K791761 — CIRCUIT, BREATHING W/WO NEBULIZER
- K791856 — Y & ELBOW W/WO PORTS
- K791469 — MANIFOLD/NEBULIZER BREATHING PRODUCTS
- K791034 — PIGGYBACK BREATHING CIRCUIT
- K791060 — RAIN-X
- K772069 — VOL. VENTILATOR SETUP W/OUT NEBULIZER
- K770581 — CORRUGATED TUBING, 770 & 771
- K770593 — CORRUGATED TUBING #770 & 771
- K770354 — TUBING, AEROSAL, DISPOSABLE
- K760993 — MECK/MILLER VENTILATION TUBE HARNESS
Data sourced from openFDA. This site is unofficial and independent of the FDA.