Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

QSM · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

189 daysmedian FDA review time
588 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252926Robotic Surgical Instruments - Permanent Cautery Hook (47018Restore Robotics2026-03-261920
K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix2025-08-201880
K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix2025-08-191760
K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix2025-08-191890
K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix2025-08-191880
K2426108mm Monopolar Curved Scissors (470179)Iconocare Health2025-03-111890
K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix2024-11-071330
K2104788mm Monopolar Curved ScissorsIconocare Health2022-09-305880

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