FDA product code JZF: Tube, Ear Suction
JZF is the FDA product code for tube, ear suction. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 5 510(k) submissions under JZF, from 5 different applicants. The average 510(k) review took 107 days (median 118).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Ear Suction |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZF clearance
Top JZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exmoor Plastics , Ltd. | 1 | 1998-01-23 |
| Steven K. Juhn | 1 | 1986-11-24 |
| Downs Surgical , Ltd. | 1 | 1985-12-23 |
| Treace Medical, Inc. | 1 | 1984-08-24 |
| Kelleher Corp. | 1 | 1982-08-12 |
Most recent JZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973587 | Exmoor Plastics , Ltd. | EXMOOR TYMPANOCENTESIS KIT (TK/1) | 1998-01-23 | 123 |
| K862903 | Steven K. Juhn | MIDDLE EAR VIEWER AND FLUID COLLECTOR | 1986-11-24 | 116 |
| K853589 | Downs Surgical , Ltd. | SHAH SELF-CLEARING MASTOID SUCTION TUBE | 1985-12-23 | 118 |
| K841357 | Treace Medical, Inc. | MICRO FLUID APPLICATOR | 1984-08-24 | 144 |
| K822010 | Kelleher Corp. | RIGID SUCTION TIPS & RELATED ITEMS | 1982-08-12 | 35 |
Recalls for JZF devices
openFDA lists no recalls for product code JZF.
Frequently asked questions
What is FDA product code JZF?
JZF is the FDA product code for tube, ear suction. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is JZF?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZF?
Across 5 cleared submissions the average was 107 days from receipt to decision (median 118).
Which companies have the most JZF clearances?
Exmoor Plastics , Ltd. (1); Steven K. Juhn (1); Downs Surgical , Ltd. (1); Treace Medical, Inc. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZF
- Run a recall and safety report across every JZF manufacturer
- Watch product code JZF 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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