Product code KXO— Obstetrics/Gynecology
AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.
- Classification name
- Monitor, Pressure, Intrauterine
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 26
- First cleared
- Most recent
Market context for product code KXO
FDA has cleared devices under product code KXO between 1979 and 1999, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1980
- 1979
Top applicants under product code KXO
Recent clearances under product code KXO
- K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
- K982565 — EASY TRANS TIP
- K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
- K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
- K961290 — IUP - TIP TRANS, IUP - PROXI TRANS
- K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
- K950708 — LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000
- K922323 — MX4042/MC4044 SERIES SIMULCATH(TM)
- K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT
- K910742 — MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
- K905563 — INTRAN PLUS
- K910227 — MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
- K901084 — ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
- K896122 — AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED
- K895763 — ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING
- K895323 — MODEL DT-BAL, BALANCE SAVER
- K894362 — MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP
- K885316 — DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A
- K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.
- K883832 — CATHETER, INTRAUTERINE AND INTRODUCER
- K862873 — IUC - INTRAUTERINE CATHETER
- K862182 — AMNIOINFUSION CATHETER
- K860101 — MX4040 INTRAUTERINE PRESSURE MONITORING KIT
- K801758 — MMI/GAELTEC CATHETER INTRAUTERINE
- K790678 — INTRAUTERINE CATHETER TIP
- K790418 — MODEL 8100 PRE-FILLED INTRAUTERINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.