BSZ · Gas-Machine, Anesthesia · Chrysalis Intelligence

Device class

Class II

Regulation 868.5160

Total clearances

2020-03-18 → 2026-06-25

Last 12 months

Unique sponsors

Classification details

Medical specialty

Anesthesiology

Review panel

Regulation number

868.5160

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
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2	1	2026-06-25
Drägerwerk AG Co. Kgaa	2	1	2026-05-21
Datex-Ohmeda, Inc.	1	0	2023-03-28
Codonics.Incorporated	1	0	2025-07-11
Maquet Critical Care AB	1	0	2020-03-18

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
99140	CPT	—	Low	Anesthesia service code; device itself not typically separately billed

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-25	K253330	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	A5 Anesthesia System (A5); A7 Anesthesia System (A7)
2026-05-21	K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
2025-07-11	K251352	Codonics.Incorporated	Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
2023-07-23	K230931	Drägerwerk AG Co. Kgaa	Atlan
2023-03-28	K213867	Datex-Ohmeda, Inc.	Carestation 750/750c
2021-03-26	K201957	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	A8, A9 Anesthesia System
2020-03-18	K191027	Maquet Critical Care AB	Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System