Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2026 — Predicate Candidate Screening
2,017 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
132 daysmedian FDA review time
268 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253505 | Zamenix™ P | Roen Surgical, Inc. | 2026-08-07 | 280 | 0 |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | 2026-08-07 | 256 | 0 |
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | 2026-08-07 | 444 | 0 |
| K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | 2026-08-07 | 60 | 0 |
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 | 358 | 0 |
| K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 | 99 | 0 |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026-08-07 | 221 | 0 |
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | 2026-08-07 | 305 | 0 |
| K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026-08-07 | 102 | 0 |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | 2026-08-07 | 266 | 0 |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 | 130 | 0 |
| K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2026-08-07 | 263 | 0 |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR- | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 | 140 | 0 |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 | 85 | 0 |
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 | 58 | 0 |
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026-08-07 | 28 | 0 |
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 | 79 | 0 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 | 88 | 0 |
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2026-08-07 | 169 | 0 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging | Nobel Biocare AB | 2026-08-06 | 234 | 0 |
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026-08-06 | 128 | 0 |
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026-08-06 | 125 | 0 |
| K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | 2026-08-06 | 192 | 0 |
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026-08-06 | 447 | 0 |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 | 86 | 0 |
| K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 3 | Mozarc Medical Us, LLC | 2026-08-06 | 300 | 0 |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpi | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026-08-06 | 62 | 0 |
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | 2026-08-06 | 226 | 0 |
| K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | 2026-08-05 | 331 | 0 |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | 2026-08-05 | 142 | 0 |
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. | 2026-08-05 | 139 | 0 |
| K261456 | Ruthinium Disc | Dental Manufacturing S.p.A. | 2026-08-05 | 96 | 0 |
| K254211 | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | 2026-08-05 | 219 | 0 |
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 | 57 | 0 |
| K260120 | NaturaJel™ Oral Wound Care Kit | HCS Innovation, LLC | 2026-08-05 | 202 | 0 |
| K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Fe | Convatec | 2026-08-05 | 152 | 0 |
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | 2026-08-05 | 48 | 0 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 | 245 | 0 |
| K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026-08-05 | 100 | 0 |
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026-08-04 | 252 | 0 |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | 2026-08-04 | 90 | 0 |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy | Shenzhen Qianyu Technology Co., Ltd. | 2026-08-04 | 62 | 0 |
| K260572 | Marrow Marxman | Medimetrix, LLC | 2026-08-04 | 166 | 0 |
| K261523 | Vertex™ Thrombectomy System | Jupiter Endovascular | 2026-08-04 | 89 | 0 |
| K254043 | TRIVANCE™ Hip Stem | Globus Medical, Inc. | 2026-08-04 | 230 | 0 |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 | 242 | 0 |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-08-04 | 27 | 0 |
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | 2026-08-03 | 41 | 0 |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-08-03 | 60 | 0 |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 | 46 | 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