FDA product code LZE: Isometer
LZE is the FDA product code for isometer. It is a Class I device, regulated under 21 CFR 888.1520 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under LZE. The average 510(k) review took 181 days (median 181).
Classification
| Field | Value |
|---|---|
| Device name | Isometer |
| Device class | Class I |
| Regulation | 21 CFR 888.1520 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LZE clearance
Top LZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharma-Plast Intl. A/S | 1 | 1995-07-17 |
Most recent LZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950178 | Pharma-Plast Intl. A/S | PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET | 1995-07-17 | 181 |
Recalls for LZE devices
openFDA lists no recalls for product code LZE.
Frequently asked questions
What is FDA product code LZE?
LZE is the FDA product code for isometer. It is a Class I device, regulated under 21 CFR 888.1520 and reviewed by the Orthopedic panel.
What device class is LZE?
Class I, regulation 21 CFR 888.1520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LZE?
Across 1 cleared submissions the average was 181 days from receipt to decision (median 181).
Which companies have the most LZE clearances?
Pharma-Plast Intl. A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LZE
- Run a recall and safety report across every LZE manufacturer
- Watch product code LZE 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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