FDA product code KTI: Bronchoscope Accessory
KTI is the FDA product code for bronchoscope accessory. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 34 510(k) submissions under KTI, 15 in the last five years, from 26 different applicants. The average 510(k) review took 133 days (median 104); 151 days on average over the last three years. FDA has posted 12 recalls for KTI devices, 3 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 | Bronchoscope Accessory |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for KTI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 121 |
| 2018 | 1 | 60 |
| 2019 | 1 | 307 |
| 2020 | 1 | 90 |
| 2021 | 1 | 156 |
| 2022 | 3 | 186 |
| 2023 | 4 | 164 |
| 2025 | 5 | 128 |
| 2026 | 3 | 174 |
Compare with all 510(k) review times · Search every KTI clearance
Top KTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Surgical Technologies America | 4 | 2020-03-18 |
| Serpex Medical, Inc. | 2 | 2025-10-08 |
| Olympus Medical Systems Corp. | 2 | 2025-03-31 |
| Merit Medical Systems, Inc. | 2 | 2022-03-08 |
| Acclarent, Inc. | 2 | 2011-03-31 |
21 more applicants have KTI clearances. See the full list in Caduvo.
Most recent KTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261274 | Cook Ireland, Ltd. | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | 2026-07-24 | 98 |
| K251478 | Finemedix Co., Ltd. | ClearTip TBNA Type | 2026-04-16 | 338 |
| K254040 | Free Flow Medical, Inc. | LungFlow Basket Catheter | 2026-03-12 | 86 |
| K251402 | Leadoptik, Inc. | LIA-1 Catheter (542-1) | 2025-12-19 | 227 |
| K252874 | Serpex Medical, Inc. | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | 2025-10-08 | 28 |
Recalls for KTI devices
12 product recalls in 6 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2025-08-06.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2023 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code KTI?
KTI is the FDA product code for bronchoscope accessory. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is KTI?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTI?
Across 34 cleared submissions the average was 133 days from receipt to decision (median 104).
Which companies have the most KTI clearances?
Olympus Surgical Technologies America (4); Serpex Medical, Inc. (2); Olympus Medical Systems Corp. (2); Merit Medical Systems, Inc. (2); Acclarent, Inc. (2).
Have KTI devices been recalled?
Yes: 12 product recalls across 6 recall events; the most recent began 2025-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code KTI
- Run a recall and safety report across every KTI manufacturer
- Watch product code KTI 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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