Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baylis Medical Technologies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
270 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. | 2026-01-18 | 30 | 0 |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePa | Baylis Medical Technologies, Inc. | 2025-10-28 | 270 | 0 |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2025-09-11 | 149 | 0 |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2024-02-28 | 188 | 0 |
| K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies, Inc. | 2023-05-30 | 90 | 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