FDA product code ETF: Unit, Examining/Treatment, Ent
ETF is the FDA product code for unit, examining/treatment, ent. It is a Class I device, regulated under 21 CFR 874.5300 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 32 510(k) submissions under ETF, from 13 different applicants. The average 510(k) review took 49 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Examining/Treatment, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.5300 |
| 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 ETF clearance
Top ETF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 17 | 1995-08-11 |
| Midmark Corp. | 3 | 1991-05-15 |
| Kelleher Corp. | 2 | 1982-11-22 |
| Premier Dental Products Co. | 1 | 1995-01-18 |
| Happersberger Otopront GmbH | 1 | 1993-08-25 |
8 more applicants have ETF clearances. See the full list in Caduvo.
Most recent ETF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953457 | Jedmed Instrument Co. | JEDMED SPECTRUM ENT CABINET | 1995-08-11 | 21 |
| K945395 | Premier Dental Products Co. | PREMIER MIRROR WARMER | 1995-01-18 | 76 |
| K932470 | Happersberger Otopront GmbH | LANGGASSE 90 | 1993-08-25 | 97 |
| K911901 | Stortz | MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE | 1991-07-26 | 88 |
| K910781 | Midmark Corp. | #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES | 1991-05-15 | 79 |
Recalls for ETF devices
openFDA lists no recalls for product code ETF.
Frequently asked questions
What is FDA product code ETF?
ETF is the FDA product code for unit, examining/treatment, ent. It is a Class I device, regulated under 21 CFR 874.5300 and reviewed by the Ear, Nose and Throat panel.
What device class is ETF?
Class I, regulation 21 CFR 874.5300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ETF?
Across 32 cleared submissions the average was 49 days from receipt to decision (median 34).
Which companies have the most ETF clearances?
Jedmed Instrument Co. (17); Midmark Corp. (3); Kelleher Corp. (2); Premier Dental Products Co. (1); Happersberger Otopront GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ETF
- Run a recall and safety report across every ETF manufacturer
- Watch product code ETF 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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