Ventway Sparrow

510(k) K202970

Ventway Sparrow is a medical device (FDA Class II; FDA product code CBK, Ventilator, Continuous, Facility Use) made by Inovytech Medical Solutions, Ltd., cleared under FDA 510(k) K202970 on 29 Jan 2021, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K202970↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK202970	Date29 Jan 2021Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K202970

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K202970
FDA product code: CBK
FDA applicant: Inovytech Medical Solutions , Ltd.

Device class: Class II
Regulation: 21 CFR Part 868.5895
Advisory committee: Anesthesiology
FDA decision: SESE Substantially Equivalent

Devices cleared under K202970

15 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K202970
		UDI-DI	Size and differences
Inlet Filter - Regular VWSP-460 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-460	07290017096964	Single use: no	On the market
Oxygen Enrichment Kit VWSP-304 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-304	07290017096933	Single use: no	On the market
Oxygen Mixer VWSP-580 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-580	07290017096926	Single use: no	On the market
Patient Circuit - Adult, 1.8m, 1 pcs, one way VWSP-450F INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-450F	07290017096766	Single use: yes	On the market
Patient Circuit - Adult, 2.4m, 1 pcs VWSP-370 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-370	07290017096889	Single use: yes	On the market
Patient Circuit - Pediatric, 1.8m, 1 pcs, one way VWSP-550F INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-550F	07290017096773	Single use: yes	On the market
Patient Circuit - Pediatric, 2.4m, 1 pcs VWSP-390 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-390	07290017096902	Single use: yes	On the market
Ventway Sparrow MRI Packaged VWSP-1000MR INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-1000MR	07290017096742	Single use: no	On the market
Ventway Sparrow MRI Robust Packaged VWSP-9000MR INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-9000MR	07290017096759	Single use: no	On the market
Ventway Sparrow MRI VWSP-100MR INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-100MR	07290017096728	Single use: no	On the market
Ventway Sparrow Packaged VWSP-1000 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-1000	07290017096810	Single use: no	On the market
Ventway Sparrow Robust Packaged VWSP-9000 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-9000	07290017096841	Single use: no	On the market
Ventway Sparrow Robust Ventilator MRI Compatible VWSP-900MR INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-900MR	07290017096735	Single use: no	On the market
Ventway Sparrow Robust VWSP-900 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-900	07290017096834	Single use: no	On the market
Ventway Sparrow VWSP-100 INOVYTEC MEDICAL SOLUTIONS LTD	VWSP-100	07290017096803	Single use: no	On the market

Similar devices

Other devices filed under FDA product code CBK (Ventilator, Continuous, Facility Use).