OMP · Negative Pressure Wound Therapy Powered Suction Pump

Device class

Class II

Regulation 878.4780

Total clearances

2020-01-15 → 2026-09-11

Last 12 months

Unique sponsors

Definition

What is Negative Pressure Wound Therapy Powered Suction Pump

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4780

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
Smith & Nephew Medical, Ltd.	8	2	2026-09-11
Genadyne Biotechnologies, Inc.	6	1	2026-03-12
3M Healthcare Business Group	4	0	2023-03-23
Cork Medical	4	1	2026-05-21
Kci USA, Inc.	3	0	2024-05-23
Clear Choice Therapeutics, Inc.	2	0	2024-02-05
Medela AG	2	0	2023-07-07
Cardinalhealth	2	0	2021-06-04
3M	2	0	2023-03-23
Zhejiang Longterm Medical Technology Co., Ltd.	2	0	2022-05-31
Alleva Medical Devices	2	0	2025-10-03
Deroyal Industries, Inc.	2	1	2025-11-21
Lightstone Medical Products (Ningbo) Co, Ltd.	1	0	2021-12-30
Molnlycke Health Care Us, LLC	1	0	2021-07-01
Applied Tissue Technologies, LLC	1	0	2022-09-21
Nexa Medical Limited	1	0	2024-07-26
Bechtel Medical, Inc.	1	1	2026-05-04
Convatec Limited, Gdc Building	1	1	2026-06-24
Alleva Medical, Ltd.	1	0	2023-03-08
Med Way, Inc.	1	0	2024-08-19
Pensar Medical, LLC	1	0	2020-10-23
Kci, A Part of 3M Health Care Business Group	1	0	2021-10-27
CG Bio Co., Ltd.	1	1	2026-06-23
Smith Nephew Medical Limited	1	0	2022-01-05
Carilex Medical, Inc.	1	0	2024-04-17

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
97606	CPT	—	High	Negative pressure wound therapy with electrical pump; powered suction device standard reimbursement code
E2401	HCPCS	—	Medium	Negative pressure wound therapy pump device supply code often paired with CPT service code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-11	K261338	Smith & Nephew Medical, Ltd.	RENASYS DYNAFLOW Kit (66807741)
2026-06-24	K253263	Convatec Limited, Gdc Building	ConvaVAC Negative Pressure Wound Therapy System
2026-06-23	K253199	CG Bio Co., Ltd.	CURASYS 2 (EMDN0003)
2026-05-27	K260646	Smith & Nephew Medical, Ltd.	RENASYS EDGE (66803126)
2026-05-21	K261291	Cork Medical	Nisus NPWT Canister 500-mL (CPC-500)
2026-05-04	K254019	Bechtel Medical, Inc.	Wound Geni NPWT System
2026-03-12	K253429	Genadyne Biotechnologies, Inc.	Genadyne ASTRA NPWT
2025-11-21	K250586	Deroyal Industries, Inc.	Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
2025-10-03	K251646	Alleva Medical Devices	extriCARE® 1000 Negative Pressure Wound Therapy System
2025-09-11	K251826	Smith & Nephew Medical, Ltd.	RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
2025-06-27	K243187	Cork Medical	Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
2025-02-18	K243576	Smith & Nephew Medical, Ltd.	RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
2024-12-23	K233614	Genadyne Biotechnologies, Inc.	Genadyne DUO NPWT
2024-08-21	K241061	Cork Medical	VERSA Negative Pressure Wound Therapy System (VCMPP-100)
2024-08-19	K241023	Med Way, Inc.	Negative Pressure Wound Therapy Device (V-Move, V-Grand)
2024-07-26	K241515	Nexa Medical Limited	NEXA NPWT System
2024-05-24	K231939	Smith & Nephew Medical, Ltd.	Renasys Edge
2024-05-23	K241134	Kci USA, Inc.	3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
2024-04-18	K230233	Deroyal Industries, Inc.	Prospera Spectruum Negative Pressure Wound Therapy System
2024-04-17	K231646	Carilex Medical, Inc.	Carilex VT¿200-i NX
2024-02-05	K232379	Clear Choice Therapeutics	PREVENT Kit
2023-12-06	K230677	Cork Medical	Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
2023-07-07	K223388	Medela AG	Invia® Integrated Dressing
2023-06-12	K221888	Genadyne Biotechnologies, Inc.	Genadyne Hybrid Foam Dressings
2023-03-23	K222859	3M	3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)