Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNX — Predicate Candidate Screening
206 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
121 days90th percentile
206clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110518 | IBAG | Future Path Medical, LLC | 2011-06-24 | 121 | 0 |
| K973364 | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY | Maersk Medical A/S | 1998-03-17 | 190 | 0 |
| K972887 | MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE | Medline Industries, Inc. | 1997-12-11 | 128 | 0 |
| K971271 | BESECURE EXTERNAL URINARY COLLECTION SYSTEM | Urology Research Intl., Inc. | 1997-08-18 | 136 | 0 |
| K971929 | AMSINO URINARY LEG BAG | Amsino Intl., Inc. | 1997-08-06 | 71 | 0 |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Welcon, Inc. | 1997-07-29 | 77 | 0 |
| K964690 | LIBERTY VALVE | Cleveland Medical Devices, Inc. | 1997-03-21 | 119 | 0 |
| K964745 | AMSINO URINARY DRAINAGE BAG | Amsino Intl., Inc. | 1997-03-18 | 112 | 0 |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-74 | Customed, Inc. | 1996-10-04 | 88 | 11 |
| K960949 | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | Bristol-Myers Squibb | 1996-04-19 | 39 | 0 |
| K952208 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-08-15 | 97 | 0 |
| K944377 | ORION'S URINARY DRAINAGE SET | Regulatory & Marketing Services, Inc. | 1994-12-06 | 90 | 0 |
| K944236 | NEEDLELESS URINE SAMPLING PORT | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-11-16 | 76 | 0 |
| K940206 | BARD URINE COLLECTION PRODUCTS MODIFICATION | C.R. Bard, Inc. | 1994-09-16 | 245 | 0 |
| K941447 | SIMPLA S4, S5, S7 | Simpla Plastics , Ltd. | 1994-07-18 | 116 | 0 |
| K935557 | URINARY DRAINAGE BAG | Puritas Health Care, Inc. | 1994-03-07 | 110 | 0 |
| K931459 | KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-06-14 | 83 | 0 |
| K925067 | SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG | Simport Plastics, Ltd. | 1993-06-10 | 248 | 0 |
| K926570 | HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 | Hollister, Inc. | 1993-05-21 | 141 | 0 |
| K921024 | URO-TOTE LEG BAG | Neotech Products, Inc. | 1992-09-02 | 183 | 0 |
| K913142 | BODEN WHEELCHAIR DRAINAGE SYSTEM | Mno Medical Products | 1991-09-23 | 69 | 0 |
| K913223 | STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES | Medical Device Inspection Co., Inc. | 1991-09-04 | 47 | 0 |
| K901320 | ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG | Ep Medical, Inc. | 1991-01-25 | 310 | 0 |
| K902417 | BAG, URINE | Gainor Medical Europe, Ltd. | 1990-07-16 | 46 | 0 |
| K896688 | URINE COLLECTOR LEG BAG | Medline Industries, Inc. | 1990-05-02 | 155 | 0 |
| K895168 | URO-BAGGIE | Cwt Workshop | 1990-03-22 | 212 | 0 |
| K896727 | 4 SURE URINARY DRAIN BAG | The Boston & Pacific Co., Inc. | 1990-02-20 | 83 | 0 |
| K896579 | GOOSEN URINARY DRAINAGE SYSTEM | Goosen Enterprises, Inc. | 1990-02-15 | 87 | 0 |
| K895957 | L.T.C. 1000 URINARY DRAINAGE BAG | Intl. Medical Marketing, Inc. | 1989-10-24 | 13 | 0 |
| K892437 | KENDALL KENGUARD URINARY LEG BAGS | The Kendal Co. | 1989-06-23 | 74 | 0 |
| K892433 | KENDALL CURITY URINARY DRAINAGE BAGS | The Kendal Co. | 1989-05-05 | 25 | 0 |
| K890551 | URINARY DRAINAGE UNIT | Consolidated Products & Services, Inc. | 1989-02-28 | 22 | 0 |
| K890550 | CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) | Consolidated Products & Services, Inc. | 1989-02-28 | 22 | 0 |
| K881678 | SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP | Hollister, Inc. | 1988-08-11 | 114 | 0 |
| K881217 | GENT-L-KARE STERILE URINARY LEG BAG | Geneva Laboratories, Inc. | 1988-07-29 | 129 | 0 |
| K881213 | GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER | Geneva Laboratories, Inc. | 1988-07-28 | 129 | 0 |
| K880034 | CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT | Lin-Mark, Inc. | 1988-03-02 | 57 | 0 |
| K874309 | URETHAL CATHETER | Medovations, Inc. | 1987-12-07 | 48 | 0 |
| K872824 | P. URINE METER, 250CC | Ni-Med, Inc. | 1987-10-14 | 90 | 0 |
| K873136 | MMG CATH-N-PLACE | Medical Technologies of Georgia | 1987-09-09 | 30 | 0 |
| K871643 | CONVEEN(R) LEG-BAG (600 ML) | Coloplast A/S | 1987-06-10 | 44 | 0 |
| K871610 | CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) | Coloplast A/S | 1987-06-10 | 47 | 0 |
| K871387 | SECOND NATURE(TM) | Advanced Clinical Products, Inc. | 1987-05-29 | 52 | 1 |
| K870504 | NORTA (TM) UROBAG | Beiersdorf, Inc. | 1987-04-01 | 56 | 0 |
| K871042 | URINE METER, 250CC | Salt Creek Medical Technologies | 1987-03-25 | 8 | 0 |
| K864188 | E-Z HOLD WITH ADHESIVE BASE.-#4065 | John F. Greer Co., Inc. | 1986-12-04 | 38 | 0 |
| K863739 | BESCURE | U-T, Inc. | 1986-10-24 | 31 | 0 |
| K863671 | PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5 | Samco Industries, Inc. | 1986-10-03 | 14 | 0 |
| K862581 | NEPHROSTOMY CONNECTING TUBE (A-50) | Advanced Clinical Products, Inc. | 1986-09-23 | 78 | 0 |
| K862580 | NEPHROSTOMY DRAINAGE KIT (A-150) | Advanced Clinical Products, Inc. | 1986-09-23 | 78 | 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