FDA product code EQL: Laryngostroboscope
EQL is the FDA product code for laryngostroboscope. It is a Class I device, regulated under 21 CFR 874.4750 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 8 510(k) submissions under EQL, from 7 different applicants. The average 510(k) review took 56 days (median 64). FDA has posted 2 recalls for EQL devices.
Classification
| Field | Value |
|---|---|
| Device name | Laryngostroboscope |
| Device class | Class I |
| Regulation | 21 CFR 874.4750 |
| 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 EQL clearance
Top EQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kay Elemetrics Corp. | 2 | 1992-05-28 |
| Richard Wolf Medical Instruments Corp. | 1 | 1999-03-17 |
| Jedmed Instrument Co. | 1 | 1989-02-15 |
| Bruel & Kjaer Industri A/S | 1 | 1984-07-18 |
| Kelleher Corp. | 1 | 1982-09-09 |
2 more applicants have EQL clearances. See the full list in Caduvo.
Most recent EQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984521 | Richard Wolf Medical Instruments Corp. | RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 | 1999-03-17 | 86 |
| K921184 | Kay Elemetrics Corp. | RLS 9100 RHINO-LARYNGEAL STROBOSCOPE | 1992-05-28 | 80 |
| K921285 | Kay Elemetrics Corp. | 9105 RIGID TELESCOPIC ENDOSCOPE | 1992-05-28 | 72 |
| K884933 | Jedmed Instrument Co. | ENDOSTROBOSCOPE IV | 1989-02-15 | 79 |
| K842090 | Bruel & Kjaer Industri A/S | RHINO-LARYNX STROBOSCOPE TYPE 4914 | 1984-07-18 | 55 |
Recalls for EQL devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-12-12.
Frequently asked questions
What is FDA product code EQL?
EQL is the FDA product code for laryngostroboscope. It is a Class I device, regulated under 21 CFR 874.4750 and reviewed by the Ear, Nose and Throat panel.
What device class is EQL?
Class I, regulation 21 CFR 874.4750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EQL?
Across 8 cleared submissions the average was 56 days from receipt to decision (median 64).
Which companies have the most EQL clearances?
Kay Elemetrics Corp. (2); Richard Wolf Medical Instruments Corp. (1); Jedmed Instrument Co. (1); Bruel & Kjaer Industri A/S (1); Kelleher Corp. (1).
Have EQL devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code EQL
- Run a recall and safety report across every EQL manufacturer
- Watch product code EQL 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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