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510(k) K250298

Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) by Clinical Innovations, LLC — Product Code HDB

K250298 is an FDA 510(k) premarket notification submitted by Clinical Innovations, LLC for the device "Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)". The FDA issued a decision of Substantially Equivalent on October 8, 2025. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Clinical Innovations, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2025
Date Received
January 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor, Vacuum, Fetal
Device Class
Class II
Regulation Number
884.4340
Review Panel
OB
Submission Type

Other clearances by Clinical Innovations, LLC

  • K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E) (May 22, 2025)
  • K223900 — babyLance Safety Heelstick (BLM, BLN, BLP) (February 24, 2023)
  • K153591 — ebb Complete Tamponade System (January 14, 2016)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K140163 — KOALA TOCO (May 29, 2014)
  • K131781 — CLEARVIEW TOTAL (May 28, 2014)
  • K110605 — ROM PLUS (November 23, 2011)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)
  • K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000 (September 17, 2003)
  • K022023 — COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSUR (January 7, 2003)

Other clearances for product code HDB

  • K041579 — MEDELA SINGLE USE SILC CUP, MODEL 077.0791 (April 21, 2005)
  • K043614 — VACULINK, MODEL VCL 3000 (April 14, 2005)
  • K021193 — FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (February 12, 2003)
  • K020447 — MITYVAC MERLIN, MODEL 10027 (April 12, 2002)
  • K013460 — SWIFT LOW PROFILE CUP (PRO CUP) (January 17, 2002)
  • K011532 — MITYVAC (July 30, 2001)
  • K981260 — KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM (September 22, 1998)
  • K980976 — AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP (August 21, 1998)
  • K980212 — MITYVAC (July 9, 1998)
  • K973942 — SWIFT DELIVERY PRODUCT #300 (December 12, 1997)

FDA data resources