Home / 510(k) Clearances / K170088

510(k) K170088

Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film by Medela AG — Product Code OMP

K170088 is an FDA 510(k) premarket notification submitted by Medela AG for the device "Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film". The FDA issued a decision of Substantially Equivalent on April 6, 2017. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Medela AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2017
Date Received
January 10, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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.

Other clearances by Medela AG

  • K253510 — Freestyle Mini Hands-free (April 10, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K251377 — Magic InBra (September 18, 2025)
  • K232608 — Duo Hands-free Breast Pump (April 12, 2024)
  • K223388 — Invia® Integrated Dressing (July 7, 2023)
  • K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) System (July 26, 2022)
  • K210759 — Solo, Swing Maxi (August 11, 2021)
  • K200508 — Pump In Style (June 15, 2020)
  • K191653 — Freestyle Flex (October 17, 2019)

Other clearances for product code OMP

  • K261338 — RENASYS DYNAFLOW Kit (66807741) (September 11, 2026)
  • K253263 — ConvaVAC™ Negative Pressure Wound Therapy System (June 24, 2026)
  • K253199 — CURASYS 2 (EMDN0003) (June 23, 2026)
  • K260646 — RENASYS EDGE (66803126) (May 27, 2026)
  • K261291 — Nisus NPWT Canister 500-mL (CPC-500) (May 21, 2026)
  • K254019 — Wound Geni NPWT System (May 4, 2026)
  • K253429 — Genadyne ASTRA NPWT (March 12, 2026)
  • K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foa (November 21, 2025)
  • K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System (October 3, 2025)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (September 11, 2025)

FDA data resources