KTI · Bronchoscope Accessory · Chrysalis Intelligence

Device class

Class II

Regulation 874.4680

Total clearances

2020-03-18 → 2026-07-24

Last 12 months

Unique sponsors

Definition

What is Bronchoscope Accessory

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 details

Medical specialty

Ear, Nose, Throat

Review panel

Regulation number

874.4680

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Serpex Medical, Inc.	2	1	2025-10-08
Olympus Medical Systems Corp.	2	0	2025-07-29
Merit Medical Systems, Inc.	1	0	2022-03-08
Disa Medinotec	1	0	2021-11-24
Alton (Shanghai) Medical Instruments Co., Ltd.	1	0	2025-03-04
Free Flow Medical, Inc.	1	1	2026-03-12
Leadoptik, Inc.	1	1	2025-12-19
Cook Ireland, Ltd.	1	1	2026-07-24
Olympus Surgical Technologies America	1	0	2020-03-18
M/S Meril Life Sciences Pvt. , Ltd.	1	0	2023-11-15
Dongguan TT Medical, Inc.	1	0	2023-03-01
Ga Health Company Limited	1	0	2023-05-11
Micro-Tech (Nanjing) Co., Ltd.	1	0	2022-07-20
Praxis Medical, LLC	1	0	2023-09-25
Finemedix Co., Ltd.	1	1	2026-04-16

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
31615	CPT	—	Medium	CPT for bronchoscopy with accessory instrument use
A4609	HCPCS	—	Medium	HCPCS for reusable bronchoscope accessory supplies

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-24	K261274	Cook Ireland, Ltd.	EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
2026-04-16	K251478	Finemedix Co., Ltd.	ClearTip TBNA Type
2026-03-12	K254040	Free Flow Medical, Inc.	LungFlow Basket Catheter
2025-12-19	K251402	Leadoptik, Inc.	LIA-1 Catheter (542-1)
2025-10-08	K252874	Serpex Medical, Inc.	Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
2025-07-29	K251664	Olympus Medical Systems Corporation	Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
2025-03-31	K250263	Olympus Medical Systems Corp.	Disposable Grasping Forceps FG-52D/FG-54D
2025-03-04	K241679	Alton (Shanghai) Medical Instruments Co., Ltd.	Disposable Cytology Brush (AF series)
2023-11-15	K231818	M/S Meril Life Sciences Pvt. , Ltd.	METIC- Airway Balloon Catheter
2023-09-25	K230778	Praxis Medical, LLC	EndoCore
2023-05-11	K230280	Ga Health Company Limited	ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
2023-03-01	K222187	Dongguan TT Medical, Inc.	Multistage Balloon Dilatation Catheter
2022-08-25	K221206	Serpex Medical, Inc.	Compass Steerable Needle
2022-07-20	K213060	Micro-Tech (Nanjing) Co., Ltd.	AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
2022-03-08	K213434	Merit Medical Systems, Inc.	Elation Pulmonary Balloon Dilation Catheter
2021-11-24	K211894	Disa Medinotec	Trachealator
2020-03-18	K193517	Olympus Surgical Technologies America	ViziShot 2 FLEX