Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2025 — Predicate Candidate Screening
3,225 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
127 daysmedian FDA review time
267 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252951 | Genesis Sleep | Neurofield, Inc. | 2025-12-31 | 106 | 0 |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, J | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-12-31 | 93 | 0 |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); | Arc Trauma, LLC | 2025-12-31 | 401 | 0 |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 2025-12-31 | 27 | 1 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 | 111 | 0 |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025-12-30 | 343 | 0 |
| K251091 | Lipids | Truvian Health | 2025-12-30 | 264 | 0 |
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multi | Techno-Path Manufacturing , Ltd. | 2025-12-30 | 496 | 0 |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | 2025-12-30 | 26 | 0 |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. | 2025-12-30 | 47 | 0 |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | 2025-12-30 | 28 | 0 |
| K251025 | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor | Covidien, LLC | 2025-12-29 | 271 | 0 |
| K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard | Covidien, LLC | 2025-12-29 | 245 | 0 |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2025-12-29 | 262 | 0 |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-12-29 | 224 | 0 |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-12-29 | 25 | 0 |
| K253343 | Celebrace Software | Celebrace | 2025-12-29 | 90 | 0 |
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 | 90 | 0 |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 2025-12-24 | 86 | 0 |
| K253342 | PICO-K | Speclipse, Inc. | 2025-12-24 | 85 | 0 |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | 2025-12-24 | 85 | 0 |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W | Shenzhen Saidi Light Therapy Technology Co., Ltd. | 2025-12-24 | 85 | 0 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 2025-12-23 | 125 | 0 |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | 2025-12-23 | 28 | 0 |
| K253072 | Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | 2025-12-23 | 91 | 0 |
| DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Contr | DiaSorin, Inc. | 2025-12-23 | 146 | 0 |
| K252145 | GEN5™ and GEN5+™ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 | 167 | 0 |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 | 84 | 0 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 | 84 | 0 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 | 146 | 0 |
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025-12-23 | 32 | 0 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 | 307 | 0 |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 | 91 | 0 |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 2025-12-23 | 1 | 0 |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurat | Healgen Scientific,, LLC | 2025-12-23 | 36 | 0 |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013 | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2025-12-23 | 179 | 0 |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Sh | Hycor Biomedical | 2025-12-23 | 137 | 0 |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Con | Bruno Vision Care, LLC | 2025-12-23 | 207 | 0 |
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025-12-23 | 194 | 0 |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SK | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-23 | 167 | 0 |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | 2025-12-23 | 109 | 0 |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC | 2025-12-23 | 179 | 0 |
| K251958 | VEINOPLUS Back | Dynapulse Medical | 2025-12-23 | 181 | 0 |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | 2025-12-23 | 29 | 0 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 | 85 | 0 |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12 | Edan Instruments, Inc. | 2025-12-23 | 243 | 0 |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJ | Dongguan Yijiaming Technology Co., Ltd. | 2025-12-23 | 89 | 0 |
| K253122 | Sim&Size | Sim&Cure | 2025-12-23 | 89 | 0 |
| DEN250004 | QIKCAP System | Hai Solutions | 2025-12-23 | 327 | 0 |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | 2025-12-23 | 162 | 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