510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HIOClass I

Sampler, Amniotic Fluid (Amniocentesis Tray)

21 CFR 884.1550 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HIO is the FDA product code for Sampler, Amniotic Fluid (Amniocentesis Tray), a class I device type, regulated under 21 CFR 884.1550. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HIO
Device name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation
21 CFR 884.1550
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
1

Clearances, product code HIO

By decision year
20 clearances under product code HIO with a decision year between 1976 and 1996, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HIO by decision year
YearClearances
19761
19801
19831
19852
19862
19893
19903
19911
19923
19931
19962

Applicants with the most clearances

Product code HIO
Applicants holding the most 510(k) clearances under product code HIO
ApplicantClearances
E-Z-EM, Inc3
Universal Medical Instrument Corp.2
Aptek, Ltd.1
Baxter Healthcare Corporation1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Cameo, Inc.1
Concord/Portex1
Contour Fabricators of Florida, Inc.1
Cook Ob/Gyn1
Critical Specialties, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order