FDA product code LWE: Bone Marrow Collection/Transfusion Kit
LWE is the FDA product code for bone marrow collection/transfusion kit. It is a Class II device, reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under LWE, from 3 different applicants. The average 510(k) review took 128 days (median 99). FDA has posted 1 recall for LWE devices.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Bone Marrow Collection/Transfusion Kit |
| Device class | Class II |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LWE clearance
Top LWE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Promedical , Ltd. | 1 | 1995-07-17 |
| Proact, Ltd. | 1 | 1991-11-01 |
| Baxter Healthcare Corp | 1 | 1987-11-06 |
Most recent LWE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952350 | Promedical , Ltd. | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) | 1995-07-17 | 59 |
| K913306 | Proact, Ltd. | BONE-TEMNO/STERNUM-TEMNO | 1991-11-01 | 99 |
| K871198 | Baxter Healthcare Corp | BONE MARROW COLLECTION KIT AND STAND | 1987-11-06 | 227 |
Recalls for LWE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-10-18.
Frequently asked questions
What is FDA product code LWE?
LWE is the FDA product code for bone marrow collection/transfusion kit. It is a Class II device, reviewed by the General Hospital panel.
What device class is LWE?
Class II. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LWE?
Across 3 cleared submissions the average was 128 days from receipt to decision (median 99).
Which companies have the most LWE clearances?
Promedical , Ltd. (1); Proact, Ltd. (1); Baxter Healthcare Corp (1).
Have LWE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-10-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LWE
- Run a recall and safety report across every LWE manufacturer
- Watch product code LWE 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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