Predicate Watch — June 2026

311 devices cleared in June 2026. 112 of them named another company's device as the predicate they claim substantial equivalence to, across 89 distinct incumbents.

FDA does not publish predicate citations as data — they exist only as text inside each submission's PDF. Everything below is extracted from those documents and every claim carries its K-numbers so you can check it.

Cited for the first time

These companies had a device named as a predicate by an outside firm for the first time. Someone has decided their product is the thing to be equivalent to.

• New Cos — VisionAir Solutions (K261541) cleared VisionAir Enhanced Stock Stent, citing Patient-Specific Airway Stent (K182743).
• Gyder Surgical — Orthalign (K253507) cleared Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee, citing GYDER® Hip System (K243387).
• Pollogen — Lumenis Be (K253803) cleared MILAN System, citing Legend X Applicator VO (K240999).
• Shenzhen Kaiyan Medical Equipment — The Beauty Tech Group (K260715) cleared CurrentBody Skin LED Multi Light Therapy Mask (MK-110D), citing Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (K260129).
• Tonica Elektronik — Wave Neuroscience (K260402) cleared MeRT System, citing MagVenture TMS Therapy System (K251119).
• Terrats Medical SL — Sic Invent (K252904) cleared SIC Abutments including CAD/CAM Solutions, citing DESS Dental Smart Solutions (K233316).
• Materialise — CustoMED (K260116) cleared CustoMED Viewer, citing SurgiCase Viewer (K170419).
• Vision Rt — Lap Laser Applikationen (K253004) cleared LUNA 3D, citing AlignRT Plus (K233622).

Drawing the most competitive interest

• Nova Biomedical — 2 clearances from 2 different companies (Abbott Point of Care, Roche Diagnostics)
• Truabutment — 2 clearances from 2 different companies (BioHorizons Implant Systems, Inosys)

Entering the US market

Non-US firms clearing devices against US incumbents' predicates.

• Roosin Medical (K254034) cleared Roosin Collagen Powder, citing Strukmyer Medical's CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle (K171645).
• Touchbeauty Beauty & Health (Shenzhen) (K260179) cleared VITA Multi-Function Head Brush (TB-2343F, TB-2442F), citing Xtreem Pulse's PureLift Pro Plus (K221443).
• Lap Laser Applikationen (K253004) cleared LUNA 3D, citing Vision Rt's AlignRT Plus (K233622).
• Keya Medical Technology (K260497) cleared DEEPVESSEL Plaque, citing Cedars-Sinai Medical Center: Aim's Autoplaque (K212758).
• Hangzhou Qiantang Longyue Biotechnology (K260301) cleared Vial Adapter, citing B.Braun Medical's Mini Spike Plus 6/8R (K201469).
• Materialise (K260802) cleared Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, citing DePuy Orthopaedics's DEPUY GLOBAL SHOULDER CROSSLINK GLENOID (K052472).

Oldest predicates still in use

Devices cleared this month on the back of decades-old clearances.

• Boston Scientific (K260428) cited WILSON-COOK CYSTOTOME (K022595, cleared 2002-10-17 — 24 years)
• ElectroWire Medical (K261745) cited MEGA POWER ELECTROSURGICAL GENERATOR (K050579, cleared 2005-03-24 — 21 years)
• Materialise (K260802) cited DEPUY GLOBAL SHOULDER CROSSLINK GLENOID (K052472, cleared 2005-10-06 — 21 years)
• Hass (K260859) cited IPS E.MAX CAD/IPS E.MAX ZIRCAD (K051705, cleared 2005-10-14 — 21 years)

Check any company's full citation list at prediget.com. Method: 510(k) summary PDFs parsed for predicate sections; same-corporate-family citations excluded.