FDA product code IQG: Adaptor, Holder, Syringe
IQG is the FDA product code for adaptor, holder, syringe. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under IQG, from 3 different applicants. The average 510(k) review took 144 days (median 172).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Holder, Syringe |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | HO — General Hospital |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IQG clearance
Top IQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medicool, Inc. | 1 | 2008-07-11 |
| 41 Industries, LLC | 1 | 2008-01-25 |
| Hospira, Inc. | 1 | 2006-12-11 |
Most recent IQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073555 | Medicool, Inc. | INSULIN PROTECTOR | 2008-07-11 | 206 |
| K072174 | 41 Industries, LLC | INSUCOZI INSULIN VIAL COVER | 2008-01-25 | 172 |
| K063180 | Hospira, Inc. | ISECURE SYRINGE CARTRIDGE HOLDER | 2006-12-11 | 53 |
Recalls for IQG devices
openFDA lists no recalls for product code IQG.
Frequently asked questions
What is FDA product code IQG?
IQG is the FDA product code for adaptor, holder, syringe. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the General Hospital panel.
What device class is IQG?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQG?
Across 3 cleared submissions the average was 144 days from receipt to decision (median 172).
Which companies have the most IQG clearances?
Medicool, Inc. (1); 41 Industries, LLC (1); Hospira, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IQG
- Run a recall and safety report across every IQG manufacturer
- Watch product code IQG 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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