BZQ · Monitor, Breathing Frequency · Chrysalis Intelligence

Device class

Class II

Regulation 868.2375

Total clearances

2020-01-30 → 2026-06-25

Last 12 months

Unique sponsors

Classification details

Medical specialty

Anesthesiology

Review panel

Regulation number

868.2375

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
Linshom Medical, Inc.	2	1	2025-09-26
Respiree Pte, Ltd.	2	0	2025-08-05
Philips Medical Systems Nederland B.V.	1	0	2025-04-04
Linshom Management, LLC	1	0	2020-01-30
Sound Life Sciences, Inc.	1	0	2021-11-23
Hill-Rom, Inc.	1	0	2021-03-04
Edwards Lifesciences, LLC	1	1	2026-06-11
Heroic Faith International , Ltd.	1	0	2025-02-28
Makani Science, Inc.	1	0	2025-03-28
Turtle Shell Technologies Private Limited	1	0	2022-12-15
Rtm Vital Signs, LLC	1	0	2025-06-27
Circadia Technologies, Ltd.	1	0	2020-06-24
Baxter Healthcare Corproration	1	0	2022-11-18
Pmd Solutions	1	0	2022-10-07
Intelligent Dots, LLC	1	1	2026-06-25
Faceheart Corp.	1	0	2025-04-09

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
94014	CPT	—	Medium	Spirometry with bronchodilator; breathing frequency monitoring component

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-25	K253274	Intelligent Dots, LLC	BedDot (G1)
2026-06-11	K251326	Edwards Lifesciences, LLC	Respiration Rate algorithm
2025-09-26	K250093	Linshom Medical, Inc.	Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
2025-08-05	K250934	Respiree Pte, Ltd.	Respiree Cardio- Respiratory Monitor System
2025-06-27	K243183	Rtm Vital Signs, LLC	RTMsense Respiratory Monitoring System
2025-04-09	K243966	Faceheart Corp.	FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
2025-04-04	K242001	Philips Medical Systems Nederland B.V.	Philips VSC-MEDlib
2025-03-28	K233953	Makani Science, Inc.	Makani Science Respiration Monitoring System
2025-02-28	K242798	Heroic Faith International , Ltd.	Airmod
2024-09-11	K240271	Linshom Medical, Inc.	Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
2023-03-08	K223681	Respiree Pte, Ltd.	Respiree Cardio-Respiratory Monitor
2022-12-15	K221555	Turtle Shell Technologies Private Limited	Dozee VS
2022-11-18	K223246	Baxter Healthcare Corproration	Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
2022-10-07	K220111	Pmd Solutions	RespiraSense
2021-11-23	K211387	Sound Life Sciences, Inc.	Breathe Easy Mobile Respiratory Monitor (MRM)
2021-03-04	K202018	Hill-Rom, Inc.	Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
2020-06-24	K200445	Circadia Technologies, Ltd.	The C100 Contactless Breathing Monitor
2020-01-30	K190734	Linshom Management, LLC	Linshom Respiratory Monitoring Device (LRMD)