FDA product code LBL: Tube, Tympanostomy, Porous Polyethylene
LBL is the FDA product code for tube, tympanostomy, porous polyethylene. It is a Class II device, regulated under 21 CFR 874.3880 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under LBL. The average 510(k) review took 152 days (median 152).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tympanostomy, Porous Polyethylene |
| Device class | Class II |
| Regulation | 21 CFR 874.3880 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LBL clearance
Top LBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J.S. Medical Assoc. | 1 | 1990-06-18 |
Most recent LBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900218 | J.S. Medical Assoc. | J&S HDL CHOLESTEROL PRECIPITATING REAGENT | 1990-06-18 | 152 |
Recalls for LBL devices
openFDA lists no recalls for product code LBL.
Frequently asked questions
What is FDA product code LBL?
LBL is the FDA product code for tube, tympanostomy, porous polyethylene. It is a Class II device, regulated under 21 CFR 874.3880 and reviewed by the Ear, Nose and Throat panel.
What device class is LBL?
Class II, regulation 21 CFR 874.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBL?
Across 1 cleared submissions the average was 152 days from receipt to decision (median 152).
Which companies have the most LBL clearances?
J.S. Medical Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBL
- Run a recall and safety report across every LBL manufacturer
- Watch product code LBL 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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