Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
1 — Predicate Candidate Screening
32,815 FDA 510(k) clearances under this device class; the 50 most recent screened below.
134 daysmedian FDA review time
315 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | 2026-08-07 | 444 | 0 |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 | 86 | 0 |
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemot | Hartalega NGC Sdn. Bhd. | 2026-07-28 | 159 | 0 |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | 2026-07-24 | 359 | 0 |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* | O&M Halyard, Inc. | 2026-07-21 | 36 | 0 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with C | Hartalega NGC Sdn. Bhd. | 2026-07-20 | 201 | 0 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Co | Sw Technologies, Inc. | 2026-06-24 | 352 | 0 |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted whee | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | 82 | 0 |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | 82 | 0 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 | 199 | 0 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with C | Hartalega NGC Sdn. Bhd. | 2026-06-17 | 92 | 0 |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | 2026-06-11 | 87 | 0 |
| K261174 | RxSight® Insertion Device | Rxsight, Inc. | 2026-06-10 | 62 | 0 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use | S&S Glove Corporation | 2026-06-03 | 91 | 0 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 | 83 | 0 |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 | 95 | 0 |
| K260295 | Helio Kids; Apex P | Motion Composites | 2026-05-28 | 119 | 0 |
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | 2026-05-28 | 125 | 0 |
| K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited | 2026-05-22 | 242 | 0 |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 | 150 | 0 |
| K253911 | Derma-2 | Neko Health AB | 2026-05-20 | 163 | 0 |
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 | 87 | 0 |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 | 103 | 0 |
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | 2026-04-15 | 230 | 0 |
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | 2026-04-07 | 22 | 0 |
| K250518 | SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. | 2026-04-02 | 405 | 0 |
| K250516 | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | 2026-04-02 | 405 | 0 |
| K253582 | Medical Imaging Calibration Feature (MICF) | Apple, Inc. | 2026-04-01 | 135 | 0 |
| K260319 | K5 wheelchair (16” with swing-away footrest 18” with swing-a | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 | 60 | 0 |
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 | 122 | 0 |
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | 2026-01-30 | 269 | 0 |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 | 71 | 0 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 | 119 | 0 |
| DEN250005 | Sana Device | Sana Health | 2026-01-16 | 319 | 0 |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | 2026-01-14 | 173 | 0 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Colo | Kossan International Sdn Bhd | 2026-01-13 | 153 | 0 |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 2026-01-12 | 206 | 0 |
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | 2026-01-12 | 252 | 0 |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM | Foshan Topmed Dental Co., Ltd. | 2026-01-12 | 252 | 0 |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026-01-12 | 224 | 0 |
| K251091 | Lipids | Truvian Health | 2025-12-30 | 264 | 0 |
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025-12-23 | 194 | 0 |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 | 91 | 0 |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 | 91 | 0 |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus S | ACON Laboratories, Inc. | 2025-11-26 | 177 | 0 |
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collect | Medical Wire & Equipment Company (Bath), Ltd. | 2025-11-26 | 426 | 0 |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-11-21 | 87 | 0 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, | Mercator Medical (Thailand), Ltd. | 2025-11-17 | 217 | 0 |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | 2025-11-04 | 250 | 0 |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 2025-11-03 | 159 | 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