FDA product code EQH: Source, Carrier, Fiberoptic Light
EQH is the FDA product code for source, carrier, fiberoptic light. It is a Class I device, regulated under 21 CFR 874.4350 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 49 510(k) submissions under EQH, from 26 different applicants. The average 510(k) review took 98 days (median 71). FDA has posted 1 recall for EQH devices.
Classification
| Field | Value |
|---|---|
| Device name | Source, Carrier, Fiberoptic Light |
| Device class | Class I |
| Regulation | 21 CFR 874.4350 |
| 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 EQH clearance
Top EQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aspen Laboratories, Inc. | 10 | 1986-02-28 |
| Treace Medical, Inc. | 4 | 1983-06-16 |
| Kelleher Corp. | 4 | 1982-10-22 |
| Jedmed Instrument Co. | 3 | 1995-11-13 |
| Luxtec Corp. | 3 | 1987-05-22 |
21 more applicants have EQH clearances. See the full list in Caduvo.
Most recent EQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945876 | Wells Johnson Co. | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | 1995-12-04 | 368 |
| K954184 | Jedmed Instrument Co. | JED-LIGHT FIBEROPTIC LIGHT SOURCE | 1995-11-13 | 68 |
| K951829 | Laser-Optik-Systeme GmbH & Co. KG | COLD LIGHT SOURCE LOS 150 | 1995-07-10 | 81 |
| K932771 | Xomed-Treace, Inc. | BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE | 1994-08-24 | 442 |
| K941661 | Gm Engineering, Inc. | GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT | 1994-08-23 | 140 |
Recalls for EQH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-02-07.
Frequently asked questions
What is FDA product code EQH?
EQH is the FDA product code for source, carrier, fiberoptic light. It is a Class I device, regulated under 21 CFR 874.4350 and reviewed by the Ear, Nose and Throat panel.
What device class is EQH?
Class I, regulation 21 CFR 874.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EQH?
Across 49 cleared submissions the average was 98 days from receipt to decision (median 71).
Which companies have the most EQH clearances?
Aspen Laboratories, Inc. (10); Treace Medical, Inc. (4); Kelleher Corp. (4); Jedmed Instrument Co. (3); Luxtec Corp. (3).
Have EQH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-02-07.
Next steps
- Run an FDA pathway report with predicate devices for product code EQH
- Run a recall and safety report across every EQH manufacturer
- Watch product code EQH 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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