Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXF — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
183 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261745 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | 2026-06-26 | 30 | 0 |
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF23 | Pressure Products Medical Device Manufacturing, LLC | 2026-03-13 | 105 | 0 |
| K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | 2026-02-27 | 29 | 0 |
| K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | 2025-08-27 | 26 | 0 |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW | Circa Scientific, Inc. | 2025-05-01 | 30 | 0 |
| K243193 | Cross Wise™ Multi-Use RF Adapter Cable | Circa Scientific, Inc. | 2024-11-26 | 57 | 0 |
| K242076 | VersaCross™ RF Wire | Baylis Medical Company | 2024-11-01 | 108 | 0 |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW | Circa Scientific, Inc. | 2024-09-26 | 132 | 0 |
| K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 2024-05-01 | 30 | 0 |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connect | Cross Vascular, Inc. | 2023-10-12 | 28 | 0 |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon At | Edwards Lifesciences, LLC | 2022-08-22 | 88 | 0 |
| K211910 | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | 2021-07-19 | 28 | 0 |
| K182399 | Park Blade Septostomy Catheter | Cook Incorporated | 2019-04-04 | 212 | 0 |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015-06-17 | 90 | 1 |
| K073326 | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | 2008-05-28 | 183 | 1 |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | 2003-12-10 | 169 | 0 |
| K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | 2001-07-12 | 52 | 0 |
| K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOM | Baylis Medical Co., Inc. | 2001-02-01 | 734 | 0 |
| K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | 2000-07-12 | 27 | 0 |
| K860806 | REGULATED PRESSURE INJECTOR | Target Therapeutics | 1986-03-31 | 27 | 0 |
| K801031 | BLADE SEPTOSTOMY CATHETER | Cook, Inc. | 1980-07-28 | 88 | 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