Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Baylis Medical Company, Inc. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
236 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251325 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2025-05-29 | 30 | 0 |
| K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2024-07-12 | 28 | 0 |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Company, Inc. | 2023-12-20 | 236 | 0 |
| K233647 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2023-12-14 | 30 | 0 |
| K213898 | ProTrack Pigtail Wire | Baylis Medical Company, Inc. | 2023-03-01 | 442 | 0 |
| K221351 | Mechanical Guidewire | Baylis Medical Company, Inc. | 2022-12-19 | 223 | 0 |
| K213582 | Epicardial Access System | Baylis Medical Company, Inc. | 2022-06-30 | 230 | 0 |
| K220414 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2022-05-09 | 84 | 0 |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020-06-12 | 29 | 0 |
| K191546 | Epicardial Access System | Baylis Medical Company, Inc. | 2019-08-02 | 51 | 0 |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnost | Baylis Medical Company, Inc. | 2019-06-07 | 163 | 0 |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Elec | Baylis Medical Company, Inc. | 2019-06-07 | 163 | 0 |
| K183655 | VersaCross Transseptal Sheath | Baylis Medical Company, Inc. | 2019-05-20 | 144 | 3 |
| K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Company, Inc. | 2019-04-17 | 30 | 0 |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019-03-21 | 232 | 0 |
| K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019-01-02 | 174 | 0 |
| K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017-01-31 | 200 | 0 |
| K161878 | PORTAGE System | Baylis Medical Company, Inc. | 2016-09-26 | 80 | 0 |
| K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2015-11-24 | 123 | 0 |
| K151009 | Nexus Suture | Baylis Medical Company, Inc. | 2015-08-18 | 125 | 0 |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015-06-17 | 90 | 1 |
| K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Company, Inc. | 2015-06-16 | 285 | 0 |
| K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 | Baylis Medical Company, Inc. | 2013-08-30 | 31 | 0 |
| K122278 | BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR | Baylis Medical Company, Inc. | 2012-11-07 | 100 | 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