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510(k) K250897

Koala Intrauterine Pressure Catheter (IPC-5000E) by Clinical Innovations, LLC — Product Code HFN

K250897 is an FDA 510(k) premarket notification submitted by Clinical Innovations, LLC for the device "Koala Intrauterine Pressure Catheter (IPC-5000E)". The FDA issued a decision of Substantially Equivalent on May 22, 2025. The device falls under product code HFN (Transducer, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Clinical Innovations, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2025
Date Received
March 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

Other clearances by Clinical Innovations, LLC

  • K250298 — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vac (October 8, 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 HFN

  • K974389 — KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHE (February 19, 1998)
  • K973746 — PRE-FILLED SYRINGE FOR KOALA IUP (November 24, 1997)
  • K961424 — INTRAN 500 (July 10, 1996)
  • K954955 — STORC INTRAUTERINE PRESSURE CATHETER (April 17, 1996)
  • K955443 — INTRAN PLUS (February 20, 1996)
  • K920375 — DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (October 27, 1992)
  • K882224 — ULTRANS DISPOSABLE INTRAUTERINE (October 12, 1989)
  • K893503 — SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS (June 12, 1989)

FDA data resources