Chrysalis Intelligence · Product Codes · BTR

BTR · Unclassified

15 clearances · 11 unique sponsors

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Device class

—

Regulation —

Total clearances

15

2020-01-10 → 2026-06-12

Last 12 months

3

Unique sponsors

11

Classification details

Medical specialty

—

Review panel

—

Regulation number

—

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
Covidien, LLC	4	2	2025-10-06
Bryan Medical, Inc.	2	0	2021-10-21
Venner Medical (Singapore) Pte, Ltd.	1	0	2020-02-14
Pipeline Medical Products, LLC	1	0	2025-08-13
Teleflex Medical	1	0	2025-04-29
Teleflex Incorporated	1	0	2025-02-11
Well Lead Medical Co., Ltd.	1	0	2022-07-21
Salter Labs, Inc.	1	0	2020-01-10
Spiro Robotics	1	1	2026-06-12
William Cook Europe Aps	1	0	2025-06-11
Flexicare Medical Limited.	1	0	2025-05-20

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
A4630	HCPCS	Replacement batteries, medically necessary, transcutaneous electrical stimulator, owned by patient ✓ CMS-verified description	High	Endotracheal tube supply code
31500	CPT	—	Medium	Intubation procedure; endotracheal tube placement

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-12	K253437	Spiro Robotics	Spiro-VISTA
2025-10-06	K250173	Covidien, LLC	Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
2025-09-25	K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
2025-08-13	K243579	Pipeline Medical Products, LLC	AeroJet Ventilation Catheter
2025-06-11	K251499	William Cook Europe Aps	Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
2025-05-20	K250243	Flexicare Medical Limited.	ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
2025-04-29	K242495	Teleflex Medical	LMA Fastrach ETT SU
2025-02-11	K241451	Teleflex Incorporated	Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
2024-05-20	K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
2023-08-30	K223130	Covidien	Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
2022-07-21	K211543	Well Lead Medical Co., Ltd.	Wei Nasal Jet Tube
2021-10-21	K213028	Bryan Medical, Inc.	Tenax Laser Resistant Endotracheal Tube
2020-11-25	K200761	Bryan Medical, Inc.	Tenax Laser Resistant Endotracheal Tube
2020-02-14	K192120	Venner Medical (Singapore) Pte, Ltd.	Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm, Venner PneuX ETT (Endotracheal Tube) 8 mm, Venner PneuX ETT (Endotracheal Tube) 9 mm
2020-01-10	K190878	Salter Labs, Inc.	Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff