Vcare a: FDA 510(k) K121817, IVT Medical, Ltd.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK121817	Date17 Sep 2013Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K121817

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K121817
FDA product code: OMP

Device class: Class II
Regulation: 21 CFR Part 878.4780
Advisory committee: General, Plastic Surgery
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

V.A.C. Therapy System K062227 4 Oct 2006 FDA record

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K121817

19 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 K121817
		UDI-DI	Size and differences
Vcare Alpha Collecting Canister I.V.T. MEDICAL LTD	CC800 / Collecting Canister	07290111495106	Single use: yes	On the market
Vcare Alpha Collecting Canister + Proximal Tube I.V.T. MEDICAL LTD	Collecting Canister + Proximal Tube	07290111495205	Single use: yes	On the market
Vcare Alpha Drape Accessory Pack I.V.T. MEDICAL LTD	ACC-5DRS / Drape Accessory Pack	07290111494208	Single use: yes	On the market
Vcare Alpha Hose Adapter Accessory kit I.V.T. MEDICAL LTD	ACC-HAPT / Hose Adapter Accessory kit	07290111494109	Single use: yes	On the market
Vcare Alpha Irrigation hose adapter accessory kit I.V.T. MEDICAL LTD	ACC-IHF / Irrigation hose adapter accessory kit	07290111494000	Single use: yes	On the market
Vcare Alpha Proximal Tube I.V.T. MEDICAL LTD	SPT170 / Proximal Tube	07290111495007	Single use: yes	On the market
Vcare Alpha ROI-NPT Wound Dressing Kit 20x30 I.V.T. MEDICAL LTD	ROI-NPT Wound Dressing Kit 20x30	07290111493003	Single use: yes	On the market
Vcare Alpha ROI-NPT Wound Dressing Kit 40x45 I.V.T. MEDICAL LTD	ROI-NPT Wound Dressing Kit 40x45	07290111493102	Single use: yes	On the market
Vcare Alpha Sponge Accessory Pack 10x10 I.V.T. MEDICAL LTD	Sponge Accessory Pack 10x10	07290111492006	Single use: yes	On the market
Vcare Alpha Sponge Accessory Pack 10x20 I.V.T. MEDICAL LTD	Sponge Accessory Pack 10x20	07290111492105	Single use: yes	On the market
Vcare Alpha Sponge Accessory Pack 15x20 I.V.T. MEDICAL LTD	Sponge Accessory Pack 15x20	07290111492204	Single use: yes	On the market
Vcare Alpha Sponge Accessory Pack 20x30 I.V.T. MEDICAL LTD	Sponge Accessory Pack 20x30	07290111492303	Single use: yes	On the market
Vcare Alpha Sponge Accessory Pack 40x45 I.V.T. MEDICAL LTD	Sponge Accessory Pack 40x45	07290111492402	Single use: yes	On the market
Vcare Alpha Vcare α® Device I.V.T. MEDICAL LTD	VCA233e / Vcare α® Device	07290111490002	Single use: no	On the market
Vcare Alpha Woind Dressing Kit 40x45 I.V.T. MEDICAL LTD	SWDK4045 / Woind Dressing Kit 40x45	07290111491405	Single use: yes	On the market
Vcare Alpha Wound Dressing Kit 10x10 I.V.T. MEDICAL LTD	SWDK1010 / Wound Dressing Kit 10x10	07290111491009	Single use: yes	On the market
Vcare Alpha Wound Dressing Kit 10x20 I.V.T. MEDICAL LTD	SWDK1020 / Wound Dressing Kit 10x20	07290111491108	Single use: yes	On the market
Vcare Alpha Wound Dressing Kit 15x20 I.V.T. MEDICAL LTD	SWDK1520 / Wound Dressing Kit 15x20	07290111491207	Single use: yes	On the market
Vcare Alpha Wound Dressing Kit 20x30 I.V.T. MEDICAL LTD	SWDK 2030 / Wound Dressing Kit 20x30	07290111491306	Single use: yes	On the market

Similar devices

Other devices filed under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

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