Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baylis Medical Co., Inc. · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
286 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT | Baylis Medical Co., Inc. | 2013-01-24 | 122 | 0 |
| K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM | Baylis Medical Co., Inc. | 2012-03-13 | 286 | 0 |
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Baylis Medical Co., Inc. | 2011-04-01 | 178 | 3 |
| K102192 | INDISCAL DIGITAL MANOMETER | Baylis Medical Co., Inc. | 2011-02-23 | 203 | 0 |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | Baylis Medical Co., Inc. | 2010-08-10 | 85 | 0 |
| K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | Baylis Medical Co., Inc. | 2010-07-28 | 49 | 0 |
| K101117 | LEV-OR DILATION CATHETER OTW | Baylis Medical Co., Inc. | 2010-07-16 | 86 | 0 |
| K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES | Baylis Medical Co., Inc. | 2009-11-17 | 60 | 0 |
| K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, | Baylis Medical Co., Inc. | 2009-10-16 | 73 | 0 |
| K073326 | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | 2008-05-28 | 183 | 1 |
| K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND | Baylis Medical Co., Inc. | 2007-12-19 | 106 | 0 |
| K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | Baylis Medical Co., Inc. | 2007-07-19 | 22 | 0 |
| K062937 | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU | Baylis Medical Co., Inc. | 2007-01-08 | 102 | 1 |
| K051670 | RF TUNNELER WIRE | Baylis Medical Co., Inc. | 2006-03-30 | 281 | 0 |
| K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 | Baylis Medical Co., Inc. | 2005-11-30 | 28 | 1 |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | 2003-12-10 | 169 | 0 |
| K031951 | TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 | Baylis Medical Co., Inc. | 2003-09-11 | 79 | 0 |
| K031950 | BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG- | Baylis Medical Co., Inc. | 2003-07-17 | 23 | 0 |
| K023334 | BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 | Baylis Medical Co., Inc. | 2002-12-31 | 85 | 0 |
| K020354 | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOME | Baylis Medical Co., Inc. | 2002-05-03 | 88 | 0 |
| K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35 | Baylis Medical Co., Inc. | 2002-03-07 | 86 | 2 |
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Baylis Medical Co., Inc. | 2002-02-22 | 87 | 1 |
| K013904 | BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-11 | Baylis Medical Co., Inc. | 2002-02-12 | 78 | 0 |
| K002565 | BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTI | Baylis Medical Co., Inc. | 2001-05-03 | 259 | 0 |
| K010265 | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 | Baylis Medical Co., Inc. | 2001-04-09 | 73 | 0 |
| K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOM | Baylis Medical Co., Inc. | 2001-02-01 | 734 | 0 |
| K002389 | BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANA | Baylis Medical Co., Inc. | 2000-10-23 | 80 | 0 |
| K972846 | BMC RF CANNULA | Baylis Medical Co., Inc. | 1998-07-17 | 350 | 2 |
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