Biosense Webster, Inc.: FDA filings under this applicant name
FDA lists 76 510(k) clearances under the applicant name “Biosense Webster, Inc.” (first 1999, latest 2026), plus 8 PMA decisions, across 11 product codes in 2 review panels. Median 510(k) review time under this name: 99 days. Since 2017 the median was 124 days, against 99 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 88 |
| 2013 | 2 | 121 |
| 2014 | 3 | 140 |
| 2015 | 0 | — |
| 2016 | 1 | 126 |
| 2017 | 2 | 130 |
| 2018 | 3 | 167 |
| 2019 | 1 | 29 |
| 2020 | 5 | 186 |
| 2021 | 1 | 29 |
| 2022 | 3 | 278 |
| 2023 | 6 | 64 |
| 2024 | 2 | 92 |
| 2025 | 1 | 29 |
| 2026 | 2 | 94 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biosense Webster, Inc. took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 34 | 34 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 20 | 19 |
| OBJ | Catheter, Ultrasound, Intravascular | 9 | 9 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 8 | 8 |
| DYB | Introducer, Catheter | 3 | 3 |
| LPB | Cardiac Ablation Percutaneous Catheter | 3 | 0 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | 2 | 0 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 2 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 1 | 0 |
Plus 1 more product codes.
Review panels
- Cardiovascular (82)
- Ear, Nose and Throat (2)
Most recent Biosense Webster, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252972 | CARTO 3 EP Navigation System V8.4 | DQK | 2026-02-20 | 156 |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | DQK | 2026-01-18 | 31 |
| K252302 | CARTO 3 EP Navigation System V8.1 | DQK | 2025-08-22 | 29 |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | OBJ | 2024-06-28 | 28 |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | OBJ | 2024-06-12 | 156 |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | 2023-09-07 | 133 |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | DYB | 2023-07-10 | 55 |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | MTD | 2023-07-10 | 66 |
| K230253 | OPTRELL Mapping Catheter with TRUEref Technology | MTD | 2023-03-02 | 30 |
| K223766 | NUVISION NAV Ultrasound Catheter | OBJ | 2023-02-16 | 63 |
66 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240006 | PMA | VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) | 2024-11-06 |
| P210027 | PMA | QDOT MICRO System | 2022-11-23 |
| P040036 | PMA | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | 2006-08-11 |
| P030031 | PMA | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | 2004-11-05 |
| P010068 | PMA | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | 2002-09-27 |
Recalls
62 product recalls in 37 recall events; 5 initiated in the last five years. Most recent: 2025-01-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Biosense Webster, Inc. is the lead sponsor of 44 device studies on ClinicalTrials.gov (7 active or recruiting). Most recent:
- NCT07523750: A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation (Recruiting, started 2026-04-02)
- NCT07429214: A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF (Recruiting, started 2026-03-23)
- NCT07227532: A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System (Recruiting, started 2025-10-21)
- NCT07116525: A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter (Recruiting, started 2025-09-15)
- NCT06455098: A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (Recruiting, started 2024-06-28)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biosense, Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosense Webster, Inc.?
FDA lists 76 510(k) clearances under the applicant name “Biosense Webster, Inc.” (first 1999, latest 2026), plus 8 PMA decisions, across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biosense Webster, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosense Webster, Inc. is 99 days. Since 2017: 124 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biosense Webster, Inc.?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 34); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 20); OBJ (Catheter, Ultrasound, Intravascular, 9).
Next steps
- See all 76 Biosense Webster, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQK, Biosense Webster, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.