Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FHA — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
64 daysmedian FDA review time
166 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | Timm Research Co. | 1998-07-14 | 263 | 0 |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0 | Uromed Corp. | 1997-08-01 | 64 | 0 |
| K970308 | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINEN | Mentor Urology, Inc. | 1997-04-02 | 65 | 0 |
| K964580 | CAP-AID (IMPROVED) | Nebel, Inc. | 1997-01-10 | 56 | 0 |
| K955810 | U-TEX | Laborie Medical Technologies, Ltd. | 1996-01-24 | 29 | 0 |
| K954959 | CAP-AID | Nebl, Inc. | 1995-12-06 | 40 | 0 |
| K952841 | THE ASSISTANT | Apple Medical Corp. | 1995-08-18 | 58 | 0 |
| K896160 | WILLIAMS PENILE ANESTHETIC RETAINER | Cook Urological, Inc. | 1990-02-16 | 115 | 0 |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Dacomed Corp. | 1989-02-08 | 42 | 0 |
| K863227 | COOK-VPI CONTINENCE CUFF | Cook Urological, Inc. | 1987-02-03 | 166 | 0 |
| K780137 | CLAMP, INCONTINENCE, BAUMRUCKER | Greenwald Surgical Co., Inc. | 1978-04-28 | 93 | 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