Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Coloplast — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

200 daysmedian FDA review time
449 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241028Luja female (20051); Luja female (20052); Luja female (20054Coloplast2024-07-261020
K231891Virtue Male Sling System with Alexis Wound Retractor ConveniColoplast2023-09-25900
K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)),Coloplast2023-08-252170
K223821Self-Cath Closed SystemColoplast2023-08-022240
K221401Self-Cath and Self-Cath PlusColoplast2022-12-022000
K222059SpeediCath Flex SetColoplast2022-09-21700
K210250SpeedCath Compact MaleColoplast2022-04-264520
K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Coloplast2022-03-084490
K200820SpeediCath Compact SetColoplast2020-11-132280
K192904SpeediCath Compact SetColoplast2020-11-023840
K200142SpeediCath SoftColoplast2020-07-301900
K190620SpeediCath Flex Coude ProColoplast2019-07-101210
K180258SpeediCath StandardColoplast2018-10-252680
K173501Meridian Vaginal Positioning System (VPS)Coloplast2018-02-09880
K180070SpeediCath Flex Coude ProColoplast2018-02-02240

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