FDA product code CIE: Volumetric/Manometric, Carbon-Dioxide
CIE is the FDA product code for volumetric/manometric, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under CIE, from 6 different applicants. The average 510(k) review took 53 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Volumetric/Manometric, Carbon-Dioxide |
| Device class | Class II |
| Regulation | 21 CFR 862.1160 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CIE clearance
Top CIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hf Scientific, Inc. | 2 | 1988-04-28 |
| Instrumentation Laboratory CO | 1 | 1990-11-20 |
| American Research Products Co. | 1 | 1983-08-11 |
| James L. Geraci & Associates, Inc. | 1 | 1982-02-24 |
| Miles Laboratories, Inc. | 1 | 1980-04-02 |
1 more applicants have CIE clearances. See the full list in Caduvo.
Most recent CIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904761 | Instrumentation Laboratory CO | P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT | 1990-11-20 | 32 |
| K880967 | Hf Scientific, Inc. | MICRO CO2 APPARATUS | 1988-04-28 | 51 |
| K864313 | Hf Scientific, Inc. | CO2 REAGENT SET | 1987-03-13 | 130 |
| K832071 | American Research Products Co. | TOTAL CO2 REAGENT SET | 1983-08-11 | 45 |
| K820091 | James L. Geraci & Associates, Inc. | AIRMED SMOKE EVACUATION & FILTER | 1982-02-24 | 42 |
Recalls for CIE devices
openFDA lists no recalls for product code CIE.
Frequently asked questions
What is FDA product code CIE?
CIE is the FDA product code for volumetric/manometric, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel.
What device class is CIE?
Class II, regulation 21 CFR 862.1160. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIE?
Across 7 cleared submissions the average was 53 days from receipt to decision (median 45).
Which companies have the most CIE clearances?
Hf Scientific, Inc. (2); Instrumentation Laboratory CO (1); American Research Products Co. (1); James L. Geraci & Associates, Inc. (1); Miles Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CIE
- Run a recall and safety report across every CIE manufacturer
- Watch product code CIE 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.
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