Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FAQ — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
142 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962604 | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET | Convatec, A Division of E.R. Squibb & Sons | 1996-07-18 | 16 | 0 |
| K960217 | CPR URINE BAG | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K955609 | CONVEEN URINE BAG - STERILE | Coloplast Corp. | 1995-12-29 | 21 | 0 |
| K953767 | PROSYS BEDSIDE DRAINAGE BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-12-20 | 131 | 0 |
| K953783 | CONVEEN LEG BAG STRAP | Coloplast Corp. | 1995-09-13 | 30 | 0 |
| K951945 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-05-25 | 29 | 0 |
| K945204 | URINE COLLECTOR & ACCESSORIES | Nelmed Corp. | 1994-11-02 | 8 | 0 |
| K934052 | ALPINE REUSABLE LEG BAGS | Sierra Laboratories, Inc. | 1994-01-07 | 141 | 0 |
| K931727 | URINARY DRAINAGE BAG CADDY | Neotech Products, Inc. | 1993-07-23 | 142 | 0 |
| K926035 | BARD LEG BAG HOLDER | C.R. Bard, Inc. | 1992-12-17 | 16 | 0 |
| K924406 | CONVEEN(R) LEG BAG(500 ML) | Coloplast A/S | 1992-10-30 | 66 | 0 |
| K903611 | ILC LEG BAG HOLDER | Inman Liebelt Corp. | 1990-10-26 | 78 | 0 |
| K901219 | EXTERNAL LEG BAG | Orion Life Systems, Inc. | 1990-06-27 | 106 | 0 |
| K896129 | URINARY LEG BAG | Cypress Medical Products, Ltd. | 1990-04-16 | 175 | 0 |
| K896728 | 4 SURE URINARY LEG BAG | The Boston & Pacific Co., Inc. | 1990-02-20 | 83 | 0 |
| K780190 | CATHETER STRAP & RUINARY BAY HOLDER | Baka Manufacturing Co., Inc. | 1978-02-21 | 15 | 0 |
| K772402 | QUADRIPLEGIC URINARY DRAINAGE VALVE | Fred Sammons, Inc. | 1978-01-26 | 30 | 0 |
| K780032 | URINARY LEG BAG | C.R. Bard, Inc. | 1978-01-17 | 8 | 1 |
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