Sampler, Amniotic Fluid (Amniocentesis Tray)
The Amniotic Fluid Sampler, also known as an amniocentesis tray, is a collection of instruments used to obtain amniotic fluid from the uterus during pregnancy for prenatal diagnostic testing, such as chromosomal or genetic analysis. It is classified as FDA Class 1, meaning it presents the lowest level of risk and is subject only to general controls such as labeling, registration, and good manufacturing practices. The product code is HIO, regulated under 21 CFR 884.1550, within the Obstetrics/Gynecology medical specialty. No special risk flags apply to this device.
Basic Information
- Product Code
- HIO
- Device Class
- FDA class 1
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960203 | G.E. STERILE AMNIOCENTESIS TRAY | Mar 14, 1996 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | Mar 12, 1996 | Substantially Equivalent | CONTOUR FABRICATORS OF FLORIDA, INC. |
| K914419 | AMNIOTEST(TM) | Sep 01, 1993 | Substantially Equivalent | PRO-LAB, INC. |
| K922960 | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE | Nov 05, 1992 | Unknown | CAMEO, INC. |
| K921738 | SONO-VU US(TM), MODIFICATION | Apr 27, 1992 | Substantially Equivalent | E-Z-EM, INC. |
| K915863 | MEGA AMNIOCENTESIS KIT | Mar 30, 1992 | Unknown | MEGA MEDICAL, INC. |
| K904583 | SONO-VU US(TM) | Jun 24, 1991 | Substantially Equivalent | E-Z-EM, INC. |
| K901643 | ISOFLO(TM) AMNIOCENTESIS TRAY | Jul 25, 1990 | Substantially Equivalent | HEALTHDYNE CARDIOVASCULAR, INC. |
| K900021 | PERCU-SET(TM) | Mar 29, 1990 | Substantially Equivalent | E-Z-EM, INC. |
| K896031 | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) | Jan 12, 1990 | Substantially Equivalent | CONCORD/PORTEX |
| K894031 | PHARMASEAL GENETIC AMNIOCENTESIS TRAY | Aug 04, 1989 | Unknown | BAXTER HEALTHCARE CORP. |
| K892846 | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE | Jul 14, 1989 | Substantially Equivalent | COOK OB/GYN |
| K890463 | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY | Apr 07, 1989 | Unknown | CRITICAL SPECIALTIES, INC. |
| K862365 | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE | Jul 07, 1986 | Substantially Equivalent | SWEMED LABORATORIES, INC. |
| K854725 | HURWITZ AMNIOCENTESIS NEEDLE | Mar 17, 1986 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K850632 | PMS AMNIOCENTESIS TRAY/KIT | May 22, 1985 | Substantially Equivalent | PROFESSIONAL MEDICAL SERVICES |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Jan 31, 1985 | Substantially Equivalent | UNIVERSAL MEDICAL INSTRUMENT CORP. |
| K830019 | AMNIO CENTESES KIT W/NEEDLE | Jan 18, 1983 | Substantially Equivalent | UNIVERSAL MEDICAL INSTRUMENT CORP. |
| K802666 | APTEK ULTRASOUND PROCEDURE TRAY | Nov 26, 1980 | Substantially Equivalent | APTEK LTD. |
| K761230 | AMMOCENTESIS TRAY (KIT) | Dec 17, 1976 | Substantially Equivalent | PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.