Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FAP — Predicate Candidate Screening
85 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
241 days90th percentile
85clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | Neurovision Medical Products, Inc. | 2012-12-13 | 357 | 0 |
| K974775 | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLO | Airtronic Services, Inc. | 1998-02-19 | 59 | 0 |
| K963330 | URODYNAMIC ANALYSIS MODULE | Synectics Medical, Inc. | 1997-04-03 | 223 | 0 |
| K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER | Rusch Intl. | 1996-08-27 | 63 | 1 |
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE | Sandhill Scientific, Inc. | 1994-04-01 | 388 | 2 |
| K931179 | UROLAB SPECTRUM | Life-Tech Intl., Inc. | 1993-11-18 | 254 | 0 |
| K922476 | URO-PRO 2000 | Fiberoptic Sensor Technlogies, Inc. | 1993-07-20 | 420 | 0 |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | Synectics-Dantec | 1993-06-18 | 297 | 0 |
| K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 | Advanced Medical Products, Inc. | 1993-04-08 | 241 | 0 |
| K923464 | URODYNAMIC CATHETERS | R.L. Medical Corp. | 1993-02-05 | 206 | 0 |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Laborie Medical Technologies, Ltd. | 1992-10-20 | 68 | 0 |
| K920451 | ENDOTEK ULTRA SYSTEM | Surgitek | 1992-09-17 | 226 | 0 |
| K920777 | LABORIE URODYNAMICS PROCESSOR | R. Laborie Surgical , Ltd. | 1992-09-04 | 197 | 0 |
| K920575 | MERKUR 4000 | F.M. Wiest USA, Inc. | 1992-07-23 | 167 | 0 |
| K914300 | PHOENIX 5 URODYNAMICS SYSTEM | Aspen Medical , Ltd. | 1992-06-02 | 251 | 0 |
| K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | Browne Medical Systems, Inc. | 1992-04-10 | 56 | 0 |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | Browne Medical Systems, Inc. | 1992-04-10 | 56 | 0 |
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | Browne Medical Systems, Inc. | 1992-04-10 | 56 | 0 |
| K915484 | URETHRALPRESSURE PROFILE CATHETER | Life-Tech Intl., Inc. | 1992-02-24 | 80 | 0 |
| K915443 | URODYNAMIC CATHETER | Cook Urological, Inc. | 1992-02-19 | 76 | 0 |
| K913736 | DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST | Biosearch Medical Products, Inc. | 1992-02-07 | 171 | 0 |
| K913169 | DANTEC UD 5500 MK2 | Dantec Medical, Inc. | 1992-01-23 | 190 | 0 |
| K914891 | PULLER OPTION FOR ETUDE(TM) | Dantec Medical, Inc. | 1992-01-07 | 68 | 0 |
| K912701 | DANTEC MENUET | Dantec Medical, Inc. | 1991-12-09 | 173 | 0 |
| K912451 | URODYNAMIC RECTAL BALLOON | Cook Urological, Inc. | 1991-12-02 | 182 | 0 |
| K913323 | ETUDE (MODEL NUMBERS 24A05 & 24A06) | Dantec Medical, Inc. | 1991-09-23 | 60 | 0 |
| K911125 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 | Diagnostic Ultrasound Corp. | 1991-08-15 | 155 | 0 |
| K911091 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES | Diagnostic Ultrasound Corp. | 1991-06-10 | 90 | 0 |
| K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO | Browne Medical Systems, Inc. | 1991-06-10 | 131 | 0 |
| K910371 | URODYNAMIC MEASURING SYSTEM | Browne Medical Systems, Inc. | 1991-05-15 | 106 | 0 |
| K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM | Browne Medical Systems, Inc. | 1991-04-02 | 75 | 0 |
| K910285 | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP | Browne Medical Systems, Inc. | 1991-04-02 | 70 | 0 |
| K904646 | BCI-100 FECAL INCONTINENCE SYSTEM | Biocare Intl. | 1991-03-19 | 159 | 0 |
| K904386 | UROLAB JANUS | Life-Tech Intl., Inc. | 1990-11-27 | 64 | 0 |
| K901494 | ETUDE, URODYNAMIC INVESTIGATION SYSTEM | Dantec Medical, Inc. | 1990-10-26 | 211 | 0 |
| K902843 | BIOSEARCH ANAL BIOFEEDBACK DEVICE | Biosearch Medical Products, Inc. | 1990-09-14 | 78 | 0 |
| K902692 | DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 | Diagnostic Ultrasound Corp. | 1990-09-13 | 86 | 0 |
| K900494 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM | Synectics-Dantec | 1990-06-11 | 129 | 0 |
| K896575 | DANTEC MENUET | Dantec Medical, Inc. | 1990-05-03 | 164 | 0 |
| K884920 | RECTUM-COLON MOTILITY MONITOR | Multi-Spectrum Consulting, Inc. | 1989-12-08 | 375 | 0 |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | Dantec Electronics, Inc. | 1989-10-04 | 310 | 0 |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Medical Engineering Corp. | 1988-08-11 | 111 | 0 |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | Dantec Electronics, Inc. | 1988-04-14 | 148 | 0 |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | Dantec Electronics, Inc. | 1988-04-14 | 148 | 0 |
| K870855 | UROSCAN | Endotherapeutics | 1987-06-09 | 98 | 0 |
| K863312 | SANDHILL AMS | Sandhill | 1986-12-03 | 99 | 0 |
| K863165 | MODEL 4-SC FOUR WAY STOPCOCK | Life-Tech Intl., Inc. | 1986-10-28 | 71 | 0 |
| K863167 | MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR | Life-Tech Intl., Inc. | 1986-10-24 | 67 | 0 |
| K863168 | MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD | Life-Tech Intl., Inc. | 1986-10-24 | 67 | 0 |
| K863169 | MODEL AS-72 ADMINISTRATION SET | Life-Tech Intl., Inc. | 1986-09-09 | 22 | 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