Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KXO — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
274 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991235 | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 500 | Ludlow Technical Products | 1999-07-08 | 87 | 0 |
| K982565 | EASY TRANS TIP | Carl Schuh | 1998-09-22 | 61 | 0 |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 500 | Graphic Controls Corp. | 1998-07-14 | 208 | 0 |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOF | Graphic Controls Corp. | 1997-01-22 | 86 | 0 |
| K961290 | IUP - TIP TRANS, IUP - PROXI TRANS | Scientific Device Manufacturer, LLC | 1996-10-15 | 194 | 0 |
| K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | Graphic Controls Corp. | 1995-07-24 | 168 | 0 |
| K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | Graphic Controls Corp. | 1995-05-25 | 101 | 0 |
| K922323 | MX4042/MC4044 SERIES SIMULCATH(TM) | Medex, Inc. | 1994-06-14 | 771 | 0 |
| K920044 | DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT | Telos Medical Corp. | 1992-04-03 | 88 | 0 |
| K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | Graphic Controls Corp. | 1992-01-14 | 327 | 0 |
| K905563 | INTRAN PLUS | Utah Medical Products, Inc. | 1991-06-19 | 189 | 1 |
| K910227 | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER | Medex, Inc. | 1991-04-03 | 75 | 0 |
| K901084 | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | Healthdyne Cardiovascular, Inc. | 1990-06-01 | 86 | 0 |
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Spectramed, Inc. | 1990-01-19 | 87 | 0 |
| K895763 | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | Healthdyne Cardiovascular, Inc. | 1989-12-22 | 87 | 0 |
| K895323 | MODEL DT-BAL, BALANCE SAVER | Spectramed, Inc. | 1989-10-24 | 56 | 0 |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | Spectramed, Inc. | 1989-08-15 | 32 | 0 |
| K885316 | DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A | Hewlett-Packard Co. | 1989-03-23 | 84 | 0 |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | Spectramed, Inc. | 1989-02-01 | 274 | 0 |
| K883832 | CATHETER, INTRAUTERINE AND INTRODUCER | Telos Medical Corp. | 1988-12-13 | 95 | 0 |
| K862873 | IUC - INTRAUTERINE CATHETER | Utah Medical Products, Inc. | 1987-02-26 | 211 | 0 |
| K862182 | AMNIOINFUSION CATHETER | Michael Reese Hospital and Medical Center | 1986-08-25 | 77 | 0 |
| K860101 | MX4040 INTRAUTERINE PRESSURE MONITORING KIT | Medex, Inc. | 1986-04-14 | 94 | 0 |
| K801758 | MMI/GAELTEC CATHETER INTRAUTERINE | Medical Measurements, Inc. | 1980-08-14 | 17 | 0 |
| K790678 | INTRAUTERINE CATHETER TIP | Sonicaid, Inc. | 1979-05-11 | 32 | 0 |
| K790418 | MODEL 8100 PRE-FILLED INTRAUTERINE | Ge Medical Systems Information Technologies | 1979-03-21 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda