FDA product code EQN: Laryngoscope, Nasopharyngoscope
EQN is the FDA product code for laryngoscope, nasopharyngoscope. It is a Class II device, regulated under 21 CFR 874.4760 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 22 510(k) submissions under EQN, 1 in the last five years, from 13 different applicants. The average 510(k) review took 60 days (median 20); 270 days on average over the last three years. FDA has posted 2 recalls for EQN devices.
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Laryngoscope, Nasopharyngoscope |
| Device class | Class II |
| Regulation | 21 CFR 874.4760 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for EQN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every EQN clearance
Top EQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 6 | 1982-09-09 |
| Machida America, Inc. | 4 | 1982-05-13 |
| Shiley, Inc. | 2 | 1979-12-18 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 2026-05-15 |
| Jedmed Instrument Company | 1 | 2015-07-23 |
8 more applicants have EQN clearances. See the full list in Caduvo.
Most recent EQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252624 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ Laryngoscopes and Accessories | 2026-05-15 | 270 |
| K150248 | Jedmed Instrument Company | ORL Video NasoPharyngo-Larngoscope | 2015-07-23 | 170 |
| K132039 | Jedmed Instrument Co. | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | 2014-02-21 | 234 |
| K834172 | Imm Enterprises , Ltd. | OP-CON SURG. INSTRUMENT #7 | 1984-03-06 | 106 |
| K831255 | Eder Instrument Co, Inc. | LARYNGOSCOPE ATTACHMENT PH2000 | 1983-09-12 | 147 |
Recalls for EQN devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-12-06.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code EQN?
EQN is the FDA product code for laryngoscope, nasopharyngoscope. It is a Class II device, regulated under 21 CFR 874.4760 and reviewed by the Ear, Nose and Throat panel.
What device class is EQN?
Class II, regulation 21 CFR 874.4760. Typical premarket route: 510(k).
How long does a 510(k) take for product code EQN?
Across 22 cleared submissions the average was 60 days from receipt to decision (median 20).
Which companies have the most EQN clearances?
Kelleher Corp. (6); Machida America, Inc. (4); Shiley, Inc. (2); KARL STORZ Endoscopy-America, Inc. (1); Jedmed Instrument Company (1).
Have EQN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-12-06.
Next steps
- Run an FDA pathway report with predicate devices for product code EQN
- Run a recall and safety report across every EQN manufacturer
- Watch product code EQN 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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