Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GEI — Predicate Candidate Screening
2,312 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
261 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 | 103 | 0 |
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 | 255 | 0 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545 | Olympus Medical Systems Corp. | 2026-07-01 | 196 | 0 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 | 255 | 0 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 | 410 | 0 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Witho | Stryker Sustainability Solutions | 2026-06-18 | 112 | 0 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 | 210 | 0 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 | 14 | 0 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 | 256 | 0 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation Sy | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 | 197 | 0 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 | 186 | 0 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 | 176 | 0 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | 2026-05-29 | 46 | 0 |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 | 263 | 0 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI | Lagis Enterprise Co., Ltd. | 2026-05-20 | 237 | 0 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 | 90 | 0 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 | 135 | 0 |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026-04-10 | 123 | 0 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Penc | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 | 54 | 0 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 | 59 | 0 |
| K253405 | Prana System | Prana Surgical | 2026-04-01 | 183 | 0 |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026-03-30 | 101 | 0 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026-03-27 | 58 | 0 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026-03-25 | 124 | 0 |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 | 112 | 0 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Actio | Gyrus Acmi, Inc. | 2026-03-02 | 207 | 0 |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | 2026-02-24 | 26 | 0 |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | 2026-02-11 | 243 | 0 |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 | 235 | 0 |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II | Shenzhen Peninsula Medical Group | 2026-01-30 | 30 | 0 |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | 2026-01-27 | 264 | 0 |
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026-01-27 | 29 | 0 |
| K251254 | Ignite RF System | InMode , Ltd. | 2026-01-15 | 267 | 0 |
| K251996 | ENTire IRE System | Entire Medical , Ltd. | 2026-01-14 | 201 | 0 |
| K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | 2026-01-12 | 199 | 0 |
| K253915 | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | 2025-12-18 | 10 | 0 |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPRO | F Care Systems USA, LLC | 2025-11-24 | 89 | 0 |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | 2025-11-17 | 179 | 0 |
| K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025-11-06 | 59 | 0 |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. | 2025-11-04 | 68 | 0 |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Gen | Applied Medical Resources Corporation | 2025-10-31 | 91 | 0 |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePa | Baylis Medical Technologies, Inc. | 2025-10-28 | 270 | 0 |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M | Livsmed, Inc. | 2025-10-21 | 277 | 0 |
| K250852 | Coolfase | Asterasys Co., Ltd. | 2025-10-16 | 209 | 0 |
| K252367 | InbellaMulti System | Inbella Medical, Inc. | 2025-10-15 | 77 | 0 |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless T | Olympus Medical Systems Corporation | 2025-10-07 | 90 | 4 |
| K250688 | Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Ceda | Acotec Scientific Co., Ltd. | 2025-10-07 | 215 | 0 |
| K251899 | E Blator | New Deantronics Taiwan , Ltd. | 2025-10-01 | 103 | 0 |
| K251334 | NEW DOUBLO 2.0 | Hironic Co., Ltd. | 2025-09-29 | 152 | 0 |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applic | Olympus Winter & Ibe GmbH | 2025-09-23 | 85 | 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