FDA product code IWS: Shield, Eye, Radiological
IWS is the FDA product code for shield, eye, radiological. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 6 510(k) submissions under IWS, from 5 different applicants. The average 510(k) review took 184 days (median 174).
Classification
| Field | Value |
|---|---|
| Device name | Shield, Eye, Radiological |
| 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 IWS clearance
Top IWS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtec, Inc. | 2 | 1995-06-19 |
| Best Industries | 1 | 1994-12-30 |
| Med-Genesis, Inc. | 1 | 1994-02-22 |
| Victoreen, Inc. | 1 | 1993-11-12 |
| Burkhart Roentgen Intl., Inc. | 1 | 1992-05-28 |
Most recent IWS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945515 | Medtec, Inc. | COATED TUNGSTEN EYESHIELD | 1995-06-19 | 222 |
| K940119 | Best Industries | ROYAL MARSDEN GOLD GRAIN GUN | 1994-12-30 | 354 |
| K943011 | Medtec, Inc. | TUNGSTEN EYESHIELD | 1994-12-23 | 182 |
| K934459 | Med-Genesis, Inc. | MED-GENESIS PATIENT LASER EYE SHIELD | 1994-02-22 | 165 |
| K934362 | Victoreen, Inc. | NUCLEAR ASSOCIATES GLASSERS | 1993-11-12 | 65 |
Recalls for IWS devices
openFDA lists no recalls for product code IWS.
Frequently asked questions
What is FDA product code IWS?
IWS is the FDA product code for shield, eye, radiological. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is IWS?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWS?
Across 6 cleared submissions the average was 184 days from receipt to decision (median 174).
Which companies have the most IWS clearances?
Medtec, Inc. (2); Best Industries (1); Med-Genesis, Inc. (1); Victoreen, Inc. (1); Burkhart Roentgen Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWS
- Run a recall and safety report across every IWS manufacturer
- Watch product code IWS 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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