Chrysalis Intelligence · Product Codes · KFM

KFM · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cardiovascular · 11 clearances · 6 unique sponsors

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Device class
Class II
Regulation 870.4360
Total clearances
11
2020-04-13 → 2025-08-04
Last 12 months
0
Unique sponsors
6
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.4360
Implant
N
Life-sustain / support
N
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
Qura S.R.L 5 0 2023-10-26
Spectrum Medical S.R.L. 2 0 2025-08-04
International Biophysics Corporation 1 0 2021-03-10
Medtronic, Inc. 1 0 2020-05-21
Terumo Cardiovascular Systems Corporation 1 0 2021-11-18
Cardiacassist, Inc. 1 0 2023-08-03
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
99190 CPT — Medium CPT code for pump oxygenator procedures used with cardiopulmonary bypass
E1627 HCPCS — Medium HCPCS code for cardiopulmonary bypass pump and oxygenator
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-08-04 K251762 Spectrum Medical S.R.L. Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
2025-06-24 K250326 Spectrum Medical S.R.L. Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
2023-10-26 K233091 Qura S.R.L Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
2023-08-03 K232132 Cardiacassist, Inc. LifeSPARC System
2023-05-19 K220842 Qura S.R.L Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
2021-11-18 K200091 Terumo Cardiovascular Systems Corporation Capiox iCP Centrifugal Pump
2021-11-03 K201320 Qura S.R.L Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
2021-03-10 K193663 International Biophysics Corporation FloPump 57mL Centrifugal Pump
2020-09-02 K202169 Qura S.R.L Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
2020-05-21 K201068 Medtronic, Inc. Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
2020-04-13 K192850 Qura S.R.L Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence