LungFlow Airway Catheter
FDA 510(k) K254037 · Free Flow Medical, Inc.
510(k) numberK254037
Submission
- Device name
- LungFlow Airway Catheter
- Applicant
- Free Flow Medical, Inc.
Fremont, CA, US - Received
- December 16, 2025
- Decision date
- July 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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|---|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | Flexicare Medical Limited. | 09/02/2026SE |
| K260382 | MONARCH Platform (MON-000008)EOQ · Traditional | Auris Health, Inc. | 07/25/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | Fujifilm Corporation | 06/16/2026SE |
| K260565 | SmartClip Delivery Catheter (ADR-1715)EOQ · Traditional | Elucent Medical | 05/14/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | Olympus Medical Systems Corp. | 04/23/2026SE |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)EOQ · Traditional | MacroLux Medical Technology Co., Ltd. | 04/08/2026SE |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710USEOQ · Traditional | Fujifilm Corporation | 12/12/2025SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | Karl Storz SE & CO. KG | 12/05/2025SE |
| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
| K251894 | Himaging Bronchscope SystemEOQ · Traditional | Himaging Technology (Shanghai) Co., Ltd. | 09/23/2025SE |
More from Himaging Technology (Shanghai) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254040 | LungFlow Basket CatheterKTI · Traditional | 03/12/2026SE |
Questions and answers
When was LungFlow Airway Catheter cleared by the FDA?
LungFlow Airway Catheter (K254037) received a 510(k) decision of Substantially Equivalent on July 10, 2026, 206 days after the submission was received.
What is the product code of K254037?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.