FDA product code EOB: Nasopharyngoscope (Flexible Or Rigid)
EOB is the FDA product code for nasopharyngoscope (flexible or rigid). It is a Class II device, regulated under 21 CFR 874.4760 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 162 510(k) submissions under EOB, 18 in the last five years, from 88 different applicants. The average 510(k) review took 137 days (median 94); 221 days on average over the last three years. FDA has posted 8 recalls for EOB devices, 4 initiated in the last five years.
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 | Nasopharyngoscope (Flexible Or Rigid) |
| 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) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EOB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 246 |
| 2018 | 6 | 244 |
| 2019 | 8 | 148 |
| 2020 | 3 | 168 |
| 2021 | 2 | 310 |
| 2022 | 6 | 183 |
| 2023 | 3 | 157 |
| 2024 | 2 | 262 |
| 2025 | 3 | 245 |
| 2026 | 4 | 156 |
Compare with all 510(k) review times · Search every EOB clearance
Top EOB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 27 | 2020-08-11 |
| Vision-Sciences, Inc. | 15 | 2011-05-18 |
| Olympus Medical Systems Corp. | 5 | 2022-12-28 |
| Pentax of America, Inc. | 4 | 2022-11-16 |
| Acclarent, Inc. | 4 | 2014-04-24 |
83 more applicants have EOB clearances. See the full list in Caduvo.
Most recent EOB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261544 | Stryker Instruments | Hydro Irrigation System | 2026-06-17 | 40 |
| K254133 | Optim, LLC | ENTity USB Videoscope System | 2026-05-14 | 143 |
| K253184 | Zhuhai Wesee Meditech Co., Ltd. | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | 2026-03-25 | 180 |
| K252050 | Olympus Medical Systems Corporation | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | 2026-03-20 | 262 |
| K241731 | Resnent, LLC | Outlook Surgical Versa One System (8900139) | 2025-08-11 | 420 |
Recalls for EOB devices
8 product recalls in 7 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-04-03.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code EOB?
EOB is the FDA product code for nasopharyngoscope (flexible or rigid). 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 EOB?
Class II, regulation 21 CFR 874.4760. Typical premarket route: 510(k).
How long does a 510(k) take for product code EOB?
Across 162 cleared submissions the average was 137 days from receipt to decision (median 94).
Which companies have the most EOB clearances?
KARL STORZ Endoscopy-America, Inc. (27); Vision-Sciences, Inc. (15); Olympus Medical Systems Corp. (5); Pentax of America, Inc. (4); Acclarent, Inc. (4).
Have EOB devices been recalled?
Yes: 8 product recalls across 7 recall events; the most recent began 2024-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code EOB
- Run a recall and safety report across every EOB manufacturer
- Watch product code EOB 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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