Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JXG — Predicate Candidate Screening
259 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
275 days90th percentile
259clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682 | Integra Lifesciences Production Corporation | 2026-06-23 | 89 | 0 |
| K251598 | Intellidrop | Brainspace, Inc. | 2025-12-10 | 197 | 0 |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | 2025-11-28 | 270 | 0 |
| K252514 | EVAC-MRI | Phasor Health, LLC | 2025-11-05 | 86 | 0 |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Tec | Integra Lifesciences Production Corporation | 2025-08-08 | 267 | 0 |
| K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and End | Integra Lifesciences Production Corporation | 2025-08-06 | 264 | 0 |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Dr | Sophysa | 2025-06-20 | 267 | 0 |
| K243205 | EVAC | Phasor Health, LLC | 2025-06-03 | 245 | 0 |
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2025-03-10 | 103 | 0 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Ca | Aesculap, Inc. | 2024-12-16 | 160 | 0 |
| K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | 2024-08-20 | 89 | 0 |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bac | Integra Lifesciences Production Corporation | 2024-01-17 | 90 | 0 |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Se | Integra Lifesciences Production Corporation | 2023-12-19 | 60 | 3 |
| K231664 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | 2023-10-19 | 134 | 0 |
| K221694 | External Drainage System | Jmed(Shenzhen) Technology Limited | 2023-02-09 | 244 | 0 |
| K222422 | Polaris Valve Electronic Reading Instrument | Sophysa | 2023-02-02 | 175 | 0 |
| K223330 | Certas Plus Programmable Valves | Integra Lifesciences Production Corporation | 2023-02-01 | 93 | 1 |
| K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | 2022-12-29 | 27 | 0 |
| K222471 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA | 2022-12-08 | 114 | 0 |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Va | Integra Lifesciences Production Corporation | 2022-10-14 | 112 | 0 |
| K221918 | ReFlow System Mini | Anuncia Medical, Inc. | 2022-09-29 | 90 | 0 |
| K212641 | StrataMR II Valves and Shunts | Medtronic Neurosurgery | 2021-09-16 | 27 | 0 |
| K200950 | Ventricular Catheter | Aesculap, Inc. | 2020-05-08 | 29 | 0 |
| K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | 2020-04-29 | 33 | 0 |
| K192266 | M. Blue Adjustable Shunt System | Aesculap, Inc. | 2019-11-21 | 92 | 0 |
| K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. | 2019-11-15 | 84 | 0 |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTo | Integra LifeSciences Corporation | 2019-10-11 | 109 | 0 |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | Aesculap, Inc. | 2019-07-05 | 154 | 0 |
| K182265 | CodMan Certas Plus Programmable Valve | Integra Lifesciences Corp. | 2018-11-20 | 91 | 0 |
| K181902 | Codman Certas Plus Electronic Tool Kit | Integra Lifesciences Corp. | 2018-10-25 | 101 | 0 |
| K181622 | StrataMR guider tool | Medtronic Neurosurgery | 2018-10-01 | 103 | 0 |
| K171880 | IRRAflow CNS System | Irras, Inc. | 2018-07-13 | 385 | 0 |
| K181301 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2018-06-14 | 28 | 0 |
| K172035 | EKOS ultrasound EVD Device, EVD Control Unit | Btg International, Inc. | 2018-03-24 | 262 | 0 |
| K172759 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017-11-14 | 62 | 0 |
| K172006 | Alivio Ventricular Catheter and Flusher System (Alivio Syste | Alcyone Lifesciences, Inc. | 2017-11-09 | 129 | 0 |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF | Codman & Shurtleff, Inc. | 2017-10-16 | 55 | 0 |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundle | Codman & Shurtleff, Inc. | 2017-10-03 | 90 | 0 |
| K170599 | SureFlo EVD Catheter | Arkis Biosciences, Inc. | 2017-08-31 | 183 | 1 |
| K171586 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017-06-30 | 30 | 0 |
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shun | Aesculap, Inc. | 2017-02-27 | 236 | 0 |
| K162437 | Codman EDS3 CSF External Drainage System | Codman & Shurtleff, Inc. | 2016-10-28 | 58 | 2 |
| K161605 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2016-10-27 | 139 | 0 |
| K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Pe | Integra LifeSciences Corporation | 2016-09-22 | 65 | 0 |
| K152700 | StrataMR Valves and Shunts | Medtronic Neurosurgery | 2016-04-07 | 199 | 1 |
| K153041 | Bundled Neurological Shunts and Accessories Product Families | Integra LifeSciences Corporation | 2016-03-14 | 147 | 0 |
| K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and | Integra LifeSciences Corporation | 2016-03-04 | 155 | 0 |
| K150898 | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm | Moller Medical GmbH | 2015-12-18 | 260 | 0 |
| K152152 | Codman Certas Plus Programmable Valve | Medos International SARL | 2015-10-27 | 85 | 0 |
| K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | Aesculap, Inc. | 2015-04-02 | 294 | 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