Data / Medical devices / Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Negative Pressure Wound Therapy Non-Powered Suction Apparatus (OKO): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Negative Pressure Wound Therapy Non-Powered Suction Apparatus (product code OKO, Class 2, 21 CFR 878.4683). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on September 18, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OKO
- Device class
- 2
- Regulation
- 878.4683
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Taiwan | 1 |
| Ireland | 1 |
Makers of Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 7 | May 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Benq Materials Corporation | Gueishan Taoyuan, Taiwan | Manufacturer | 1 | May 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| KCI Manufacturing | Athlone - Co. Westmeath, Ireland | Manufacturer | 1 | November 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Kci Usa, Inc. | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | November 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Kci Usa, Inc. | San Antonio, TX, United States | Manufacturer | 1 | November 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Cordica Medical, Inc. | Haverhill, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.