Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FCM — Predicate Candidate Screening
60 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
129 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254076 | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter K | C.R. Bard, Inc. | 2026-05-29 | 162 | 0 |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Ki | Convatec Limited | 2025-06-06 | 73 | 0 |
| K223821 | Self-Cath Closed System | Coloplast | 2023-08-02 | 224 | 0 |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | Amsino International, Inc. | 2008-10-23 | 27 | 0 |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | Coloplast Manufacturing Us, LLC | 2007-06-01 | 58 | 0 |
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | Marian Medical, Inc. | 2007-03-15 | 71 | 0 |
| K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | Amsino International, Inc. | 2003-05-23 | 78 | 0 |
| K030664 | AMSURE FOLEY INSERTION TRAY | Amsino International, Inc. | 2003-05-23 | 81 | 0 |
| K011055 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS | Go Medical Industries Pty. , Ltd. | 2001-06-06 | 61 | 0 |
| K010420 | RUSCH MMG/O'NEIL CATHETER | Rusch, Inc. | 2001-05-09 | 86 | 2 |
| K003873 | MENTOR SELF-CATH CLOSED SYSTEM | Mentor Corp. | 2001-03-29 | 104 | 0 |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | Go Medical Industries Pty. , Ltd. | 2000-12-27 | 110 | 5 |
| K983010 | SELF CATH SET/SAFETY CATH | Rusch Intl. | 1999-02-12 | 168 | 0 |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Rusch, Inc. | 1996-12-17 | 74 | 0 |
| K962254 | NHMC URETHRAL CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-07-29 | 47 | 0 |
| K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | Continental Medical Laboratories, Inc. | 1996-06-21 | 24 | 0 |
| K961442 | UNIVERSAL DRAINAGE TRAY | Customed, Inc. | 1996-05-09 | 24 | 2 |
| K960214 | CPR FOLEY CAHTETER KIT | Custom Pack Reliability | 1996-04-01 | 76 | 0 |
| K960215 | CPR URETHRAL CATHETER TRAY | Custom Pack Reliability | 1996-04-01 | 76 | 0 |
| K960566 | NHMC FOLEY CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-02-29 | 20 | 0 |
| K951479 | CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSAB | Trinity Laboratories, Inc. | 1995-06-15 | 77 | 0 |
| K950390 | URETHRAL CATHETERIZATION TRAY | Medcare Custom Packaging, Inc. | 1995-05-30 | 118 | 0 |
| K951178 | UROLOGICAL CATHETER & ACCESSORIES | Deroyal Industries, Inc. | 1995-04-21 | 37 | 0 |
| K950344 | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER | Acacia Laboratories, Inc. | 1995-03-24 | 56 | 0 |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | Cypress Medical Products, Ltd. | 1995-02-27 | 48 | 0 |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT | Cypress Medical Products, Ltd. | 1995-02-27 | 47 | 0 |
| K942177 | FOLEY CATHETERIZATION TRAY | Customed, Inc. | 1994-09-08 | 127 | 0 |
| K923538 | MON-A-THERM FOLEY KIT | Mallinckrodt Medical | 1993-05-27 | 315 | 0 |
| K910653 | TOUCHLESS II INTERMITTENT CATHETER | C.R. Bard, Inc. | 1991-05-06 | 81 | 0 |
| K910022 | MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT | Medical Marketing Group | 1991-04-02 | 89 | 0 |
| K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | Welcon, Inc. | 1990-11-29 | 83 | 0 |
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS | Superior Healthcare Group, Inc. | 1990-10-04 | 71 | 7 |
| K902508 | LAKE MALE EXTERNAL CATHETERIZATION KIT | Lake Medical Products, Inc. | 1990-08-23 | 79 | 0 |
| K901185 | FOLEY CATHETER INSERTION TRAY (10CC) | Orion Life Systems, Inc. | 1990-07-20 | 129 | 1 |
| K901181 | CATHETER CARE TRAY | Orion Life Systems, Inc. | 1990-07-20 | 129 | 0 |
| K901183 | URETHRAL CATHETER TRAY (PVC) | Orion Life Systems, Inc. | 1990-07-20 | 129 | 0 |
| K901184 | URETHRAL CATHETER TRAY (LATEX) | Orion Life Systems, Inc. | 1990-07-20 | 129 | 0 |
| K901180 | FOLEY CATHETER INSERTION TRAY (30CC) | Orion Life Systems, Inc. | 1990-07-20 | 129 | 0 |
| K896212 | URETHRAL CATHETERIZATION TRAYS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-24 | 90 | 0 |
| K790254 | FOLEY CATHETERIZATION TRAY | Snyder Laboratories, Inc. | 1979-04-10 | 63 | 0 |
| K790271 | TRAY AND BAG, CATHETERIZATION | Snyder Laboratories, Inc. | 1979-03-06 | 56 | 0 |
| K790272 | TRAY, URETHRAL CATHETERIZATION | Snyder Laboratories, Inc. | 1979-03-06 | 52 | 0 |
| K780879 | URETHRO CATHETERIZATION TRAY | Abco Dealers, Inc. | 1978-07-31 | 62 | 0 |
| K780735 | URINARY CATHETER CARE SET | Shield Laboratories, Inc. | 1978-06-13 | 43 | 0 |
| K772277 | BLADDER RETENTION-CATHETHERIZATIONTRAY | Latex Ind., Inc. | 1978-03-02 | 83 | 0 |
| K772340 | CATHETERIZATION KIT 732016-732018 | Latex Ind., Inc. | 1978-02-24 | 64 | 0 |
| K772342 | ROBINSON KIT - 750014 & 750016 | Latex Ind., Inc. | 1978-02-24 | 64 | 0 |
| K780268 | BLADDER CATH KIT W/OUT CATHETER | Latex Ind., Inc. | 1978-02-24 | 7 | 0 |
| K772341 | BLADDER KIT - 734000 | Latex Ind., Inc. | 1978-02-24 | 64 | 0 |
| K780124 | CATHETERIZATION PROCED. TRAY, URETHRAL | Walpak Co. | 1978-02-21 | 28 | 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