FDA product code IWR: Holder, Syringe, Lead
IWR is the FDA product code for holder, syringe, lead. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under IWR, from 3 different applicants. The average 510(k) review took 66 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Holder, Syringe, Lead |
| Device class | Class I |
| Regulation | 21 CFR 892.6500 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWR clearance
Top IWR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Viox Corp. | 2 | 1987-07-16 |
| Victoreen, Inc. | 1 | 1994-02-19 |
| Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1 | 1981-07-02 |
Most recent IWR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934549 | Victoreen, Inc. | ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD | 1994-02-19 | 150 |
| K872656 | Viox Corp. | LEAD GLASS SHIELDS | 1987-07-16 | 9 |
| K863936 | Viox Corp. | DUFFY BOLUS INJECTOR | 1987-01-06 | 89 |
| K811688 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | TUNGSTEN SYRINGE SHIELD | 1981-07-02 | 17 |
Recalls for IWR devices
openFDA lists no recalls for product code IWR.
Frequently asked questions
What is FDA product code IWR?
IWR is the FDA product code for holder, syringe, lead. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is IWR?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWR?
Across 4 cleared submissions the average was 66 days from receipt to decision (median 53).
Which companies have the most IWR clearances?
Viox Corp. (2); Victoreen, Inc. (1); Medi-Physics Inc. Dba Nycomed Amersham Imaging (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWR
- Run a recall and safety report across every IWR manufacturer
- Watch product code IWR 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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