FDA product code HIO: Sampler, Amniotic Fluid (Amniocentesis Tray)
HIO is the FDA product code for sampler, amniotic fluid (amniocentesis tray). It is a Class I device, regulated under 21 CFR 884.1550 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 20 510(k) submissions under HIO, from 17 different applicants. The average 510(k) review took 113 days (median 88). FDA has posted 1 recall for HIO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sampler, Amniotic Fluid (Amniocentesis Tray) |
| Device class | Class I |
| Regulation | 21 CFR 884.1550 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HIO clearance
Top HIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E-Z-Em, Inc. | 3 | 1992-04-27 |
| Universal Medical Instrument Corp. | 2 | 1985-01-31 |
| GE Medical Systems | 1 | 1996-03-14 |
| Contour Fabricators of Florida, Inc. | 1 | 1996-03-12 |
| Pro-Lab, Inc. | 1 | 1993-09-01 |
12 more applicants have HIO clearances. See the full list in Caduvo.
Most recent HIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960203 | GE Medical Systems | G.E. STERILE AMNIOCENTESIS TRAY | 1996-03-14 | 58 |
| K955679 | Contour Fabricators of Florida, Inc. | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | 1996-03-12 | 89 |
| K914419 | Pro-Lab, Inc. | AMNIOTEST(TM) | 1993-09-01 | 699 |
| K922960 | Cameo, Inc. | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE | 1992-11-05 | 140 |
| K921738 | E-Z-Em, Inc. | SONO-VU US(TM), MODIFICATION | 1992-04-27 | 89 |
Recalls for HIO devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-02.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code HIO?
HIO is the FDA product code for sampler, amniotic fluid (amniocentesis tray). It is a Class I device, regulated under 21 CFR 884.1550 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIO?
Class I, regulation 21 CFR 884.1550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HIO?
Across 20 cleared submissions the average was 113 days from receipt to decision (median 88).
Which companies have the most HIO clearances?
E-Z-Em, Inc. (3); Universal Medical Instrument Corp. (2); GE Medical Systems (1); Contour Fabricators of Florida, Inc. (1); Pro-Lab, Inc. (1).
Have HIO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code HIO
- Run a recall and safety report across every HIO manufacturer
- Watch product code HIO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times