FDA product code LPZ: Container, Frozen Donor Tissue Storage
LPZ is the FDA product code for container, frozen donor tissue storage. It is a Unclassified device, reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under LPZ, from 5 different applicants. The average 510(k) review took 255 days (median 152).
Classification
| Field | Value |
|---|---|
| Device name | Container, Frozen Donor Tissue Storage |
| Device class | Unclassified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LPZ clearance
Top LPZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Travenol Laboratories, S.A. | 2 | 1986-08-28 |
| Origen Biomedical, Inc. | 1 | 2002-08-06 |
| Janus Biomedical, Inc. | 1 | 1994-03-02 |
| Hydro-Med Products, Inc. | 1 | 1987-02-10 |
| Ammerman Medical Enterprises, Inc. | 1 | 1986-08-04 |
Most recent LPZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021702 | Origen Biomedical, Inc. | CRYOBAG, MODEL CB | 2002-08-06 | 75 |
| K915471 | Janus Biomedical, Inc. | CRYOBAG | 1994-03-02 | 817 |
| K863872 | Hydro-Med Products, Inc. | TAMPER HAMPER | 1987-02-10 | 130 |
| K861761 | Travenol Laboratories, S.A. | ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE | 1986-08-28 | 114 |
| K860511 | Ammerman Medical Enterprises, Inc. | AMPU-PAK | 1986-08-04 | 174 |
Recalls for LPZ devices
openFDA lists no recalls for product code LPZ.
Frequently asked questions
What is FDA product code LPZ?
LPZ is the FDA product code for container, frozen donor tissue storage. It is a Unclassified device, reviewed by the General Hospital panel.
What device class is LPZ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LPZ?
Across 6 cleared submissions the average was 255 days from receipt to decision (median 152).
Which companies have the most LPZ clearances?
Travenol Laboratories, S.A. (2); Origen Biomedical, Inc. (1); Janus Biomedical, Inc. (1); Hydro-Med Products, Inc. (1); Ammerman Medical Enterprises, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LPZ
- Run a recall and safety report across every LPZ manufacturer
- Watch product code LPZ 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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