Chrysalis Intelligence · Product Codes · MNT

MNT · Sv70 Ventilator

Anesthesiology · 7 clearances · 6 unique sponsors

Device class
Class II
Regulation 868.5895
Total clearances
7
2020-03-09 → 2026-04-06
Last 12 months
1
Unique sponsors
6
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.5895
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Fisher & Paykel Healthcare Limited 2 0 2024-08-09
Maquet Critical Care AB 1 0 2023-07-06
Breas Medical AB 1 0 2024-12-13
Mekics Co., Ltd. 1 0 2025-05-15
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 1 1 2026-04-06
Nihon Kohden Orangemed, Inc. 1 0 2022-07-01
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.

CodeTypeDescriptionConfidenceRationale
94002 CPT Medium Ventilation assist and portable equipment rental
E0601 HCPCS Continuous positive airway pressure (cpap) device ✓ CMS-verified description Medium Continuous positive airway pressure (CPAP) device; Siemens Servo ventilator series
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-06 K252182 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. SV70 Ventilator (SV70)
2025-05-15 K242931 Mekics Co., Ltd. HFT750U
2024-12-13 K240779 Breas Medical AB Vivo 3
2024-08-09 K233643 Fisher & Paykel Healthcare, Ltd. F&P Airvo 3 NIV (PT311US)
2023-07-06 K230173 Maquet Critical Care AB Servo-air Lite Ventilator System
2022-07-01 K213521 Nihon Kohden Orangemed, Inc. Nihon Kohden NKV-330 Ventilator System
2020-03-09 K191624 Fisher & Paykel Healthcare Limited F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version