PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
FDA 510(k) clearance K213235 · decided 2022-12-21
Clearance details
- K-number
- K213235
- Device name
- PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
- Applicant
- Pentax of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-30
- Decision date
- 2022-12-21
- Days to decision
- 447 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
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| LungFlow Airway Catheter (K254037) | Free Flow Medical, Inc. | 2026-07-10 |
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| SmartClip Delivery Catheter (ADR-1715) (K260565) | Elucent Medical | 2026-05-14 |
| EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) (K252341) | Olympus Medical Systems Corp. | 2026-04-23 |
| LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (K260420) | MacroLux Medical Technology Co., Ltd. | 2026-04-08 |
| FUJIFILM Ultrasonic Endoscope EB-710US (K250863) | Fujifilm Corporation | 2025-12-12 |
| KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (K251731) | Karl Storz SE & CO. KG | 2025-12-05 |
| Ion Endoluminal System (IF1000) (K252045) | Intuitive Surgical, Inc. | 2025-09-23 |
| Himaging Bronchscope System (K251894) | Himaging Technology (Shanghai) Co., Ltd. | 2025-09-23 |
| Ion Endoluminal System (IF1000) (K252528) | Intuitive Surgical, Inc. | 2025-09-05 |
| Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (K251752) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 |
Recalls involving this device
No recalls on record reference this clearance.