Atlas FDA

KXO

26 FDA 510(k) clearances · Product code

87 daysmedian time to decision
274 days90th percentile
26clearances measured

FDA profile

Official device name
Monitor, Pressure, Intrauterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2700
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1996: 4 · 1997: 5 · 1998: 4 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) (K991235)Ludlow Technical Products1999-07-08
EASY TRANS TIP (K982565)Carl Schuh1998-09-22
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) (K974730)Graphic Controls Corp.1998-07-14
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (K964279)Graphic Controls Corp.1997-01-22
IUP - TIP TRANS, IUP - PROXI TRANS (K961290)Scientific Device Manufacturer, LLC1996-10-15
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER (K950498)Graphic Controls Corp.1995-07-24
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 (K950708)Graphic Controls Corp.1995-05-25
MX4042/MC4044 SERIES SIMULCATH(TM) (K922323)Medex, Inc.1994-06-14
DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (K920044)Telos Medical Corp.1992-04-03
MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER (K910742)Graphic Controls Corp.1992-01-14
INTRAN PLUS (K905563)Utah Medical Products, Inc.1991-06-19
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER (K910227)Medex, Inc.1991-04-03
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. (K901084)Healthdyne Cardiovascular, Inc.1990-06-01
AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED (K896122)Spectramed, Inc.1990-01-19
ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING (K895763)Healthdyne Cardiovascular, Inc.1989-12-22
MODEL DT-BAL, BALANCE SAVER (K895323)Spectramed, Inc.1989-10-24
MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP (K894362)Spectramed, Inc.1989-08-15
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A (K885316)Hewlett-Packard Co.1989-03-23
AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (K881857)Spectramed, Inc.1989-02-01
CATHETER, INTRAUTERINE AND INTRODUCER (K883832)Telos Medical Corp.1988-12-13
IUC - INTRAUTERINE CATHETER (K862873)Utah Medical Products, Inc.1987-02-26
AMNIOINFUSION CATHETER (K862182)Michael Reese Hospital and Medical Center1986-08-25
MX4040 INTRAUTERINE PRESSURE MONITORING KIT (K860101)Medex, Inc.1986-04-14
MMI/GAELTEC CATHETER INTRAUTERINE (K801758)Medical Measurements, Inc.1980-08-14
INTRAUTERINE CATHETER TIP (K790678)Sonicaid, Inc.1979-05-11
MODEL 8100 PRE-FILLED INTRAUTERINE (K790418)Ge Medical Systems Information Technologies1979-03-21

Track KXO automatically

Every clearance here is in the API, with alerts when new ones post.