Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1550](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1550) → HIO — Sampler, Amniotic Fluid (Amniocentesis Tray) # HIO · Sampler, Amniotic Fluid (Amniocentesis Tray) _Obstetrics/Gynecology · 21 CFR 884.1550 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO ## Overview - **Product Code:** HIO - **Device Name:** Sampler, Amniotic Fluid (Amniocentesis Tray) - **Regulation:** [21 CFR 884.1550](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1550) - **Device Class:** 1 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) ## Identification The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. ## Recent Cleared Devices (20 of 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K960203](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K960203.md) | G.E. STERILE AMNIOCENTESIS TRAY | GE Medical Systems | Mar 14, 1996 | SESE | | [K955679](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K955679.md) | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | Contour Fabricators of Florida, Inc. | Mar 12, 1996 | SESE | | [K914419](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K914419.md) | AMNIOTEST(TM) | Pro-Lab, Inc. | Sep 1, 1993 | SESE | | [K922960](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K922960.md) | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE | Cameo, Inc. | Nov 5, 1992 | SEKD | | [K921738](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K921738.md) | SONO-VU US(TM), MODIFICATION | E-Z-Em, Inc. | Apr 27, 1992 | SESE | | [K915863](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K915863.md) | MEGA AMNIOCENTESIS KIT | Mega Medical, Inc. | Mar 30, 1992 | SEKD | | [K904583](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K904583.md) | SONO-VU US(TM) | E-Z-Em, Inc. | Jun 24, 1991 | SESE | | [K901643](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K901643.md) | ISOFLO(TM) AMNIOCENTESIS TRAY | Healthdyne Cardiovascular, Inc. | Jul 25, 1990 | SESE | | [K900021](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K900021.md) | PERCU-SET(TM) | E-Z-Em, Inc. | Mar 29, 1990 | SESE | | [K896031](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K896031.md) | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) | Concord/Portex | Jan 12, 1990 | SESE | | [K894031](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K894031.md) | PHARMASEAL GENETIC AMNIOCENTESIS TRAY | Baxter Healthcare Corp | Aug 4, 1989 | SESD | | [K892846](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K892846.md) | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE | Cook Ob/Gyn | Jul 14, 1989 | SESE | | [K890463](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K890463.md) | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY | Critical Specialties, Inc. | Apr 7, 1989 | SESD | | [K862365](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K862365.md) | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE | Swemed Laboratories, Inc. | Jul 7, 1986 | SESE | | [K854725](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K854725.md) | HURWITZ AMNIOCENTESIS NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 17, 1986 | SESE | | [K850632](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K850632.md) | PMS AMNIOCENTESIS TRAY/KIT | Professional Medical Services | May 22, 1985 | SESE | | [K844558](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K844558.md) | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Universal Medical Instrument Corp. | Jan 31, 1985 | SESE | | [K830019](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K830019.md) | AMNIO CENTESES KIT W/NEEDLE | Universal Medical Instrument Corp. | Jan 18, 1983 | SESE | | [K802666](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K802666.md) | APTEK ULTRASOUND PROCEDURE TRAY | Aptek , Ltd. | Nov 26, 1980 | SESE | | [K761230](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K761230.md) | AMMOCENTESIS TRAY (KIT) | Pharmaseal Div., Baxter Healthcare Corp. | Dec 17, 1976 | SESE | ## Top Applicants - E-Z-Em, Inc. — 3 clearances - Universal Medical Instrument Corp. — 2 clearances - Aptek , Ltd. — 1 clearance - Baxter Healthcare Corp — 1 clearance - Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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