Pharmaseal Genetic Amniocentesis Tray
FDA 510(k) K894031 · Baxter Healthcare Corp
510(k) numberK894031
Submission
- Device name
- Pharmaseal Genetic Amniocentesis Tray
- Applicant
- Baxter Healthcare Corp
Valencia, CA, US - Received
- June 6, 1989
- Decision date
- August 4, 1989
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIO – Sampler, Amniotic Fluid (Amniocentesis Tray)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.1550
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960203 | G.E. Sterile Amniocentesis TrayHIO · Traditional | GE Medical Systems | 03/14/1996SE |
| K955679 | RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional | Contour Fabricators of Florida, Inc. | 03/12/1996SE |
| K914419 | Amniotest(Tm)HIO · Traditional | Pro-Lab, Inc. | 09/01/1993SE |
| K922960 | Various Cameo Med Amniocentesis Trays, DisposableHIO · Traditional | Cameo, Inc. | 11/05/1992SEKD |
| K921738 | Sono-Vu Us(Tm), ModificationHIO · Traditional | E-Z-Em, Inc. | 04/27/1992SE |
| K915863 | Mega Amniocentesis KitHIO · Traditional | Mega Medical, Inc. | 03/30/1992SEKD |
| K904583 | Sono-Vu Us(Tm)HIO · Traditional | E-Z-Em, Inc. | 06/24/1991SE |
| K901643 | Isoflo(Tm) Amniocentesis TrayHIO · Traditional | Healthdyne Cardiovascular, Inc. | 07/25/1990SE |
| K900021 | Percu-Set(Tm)HIO · Traditional | E-Z-Em, Inc. | 03/29/1990SE |
| K896031 | Amniotic Fluid Sampler (Amniocentesis Tray)HIO · Traditional | Concord/Portex | 01/12/1990SE |
More from Concord/Portex
| 510(k) | Device | Decision |
|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | 12/16/2025SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | 07/28/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | 02/28/2025SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
Questions and answers
When was Pharmaseal Genetic Amniocentesis Tray cleared by the FDA?
Pharmaseal Genetic Amniocentesis Tray (K894031) received a 510(k) decision of Unknown on August 4, 1989, 59 days after the submission was received.
What is the product code of K894031?
The FDA product code is HIO – Sampler, Amniotic Fluid (Amniocentesis Tray), a Class I (low risk) device regulated under 21 CFR 884.1550.