Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
K250586 is the FDA 510(k) clearance record for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory, a class II device, cleared for Deroyal Industries, Inc. on under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump). FDA's definition for product code OMP reads: "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...". FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K250586.
Clearance record
- Decision date
- Received
- (267 days to decision)
- Product code
- OMP Negative Pressure Wound Therapy Powered Suction Pump
- Regulation
- 21 CFR 878.4780
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code OMP
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 3 |
| June 2026 | 2 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
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