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510(k) and PMA: FDA Device Authorization Pathways

Released weeklyCurrent to 2026-07-31
Ledger PMA approvals on file (all time) 56911De Novo authorizations on file (all time) 2638510(k) clearances, trailing year 3143

Live state of FDA device clearance and approval: volume by pathway, review panel, and time to decision. (No AI/ML-enabled-device flag exists in this feed; that breakdown is omitted.)

175,789
clearances, live count
Added, trailing 7 d0
Added, trailing 30 d150
Most recent event2026-07-31
Update cadenceReleased weekly
Freshness Fresh · 3wk

Weekly volume

Trailing 24 weeks
8902026-02-152026-05-102026-07-26

Reviewing Panel Mix

510(k) clearances by FDA advisory panel, trailing 90 days.

Other panel255
Radiology116
Orthopedic89
Cardiovascular85
General & Plastic Surgery71
Neurology54
Dental44

Panel Rank, 2016 versus the Trailing Year

Clearance volume by advisory panel, comparing calendar 2016 with the most recent twelve months.

Other panel
604 → 867
Radiology
149 → 354
Orthopedic
127 → 291
Cardiovascular
99 → 279
General & Plastic Surgery
111 → 265
Dental
48 → 158
Neurology
44 → 140

Device Class Mix

510(k) clearances by premarket risk classification, trailing 90 days.

Class II673
Unclassified / other23
Class I18

Days to Decision

Time from FDA receipt to clearance decision, trailing 90 days.

80
0-30 days
159
31-90 days
220
91-180 days
235
181-365 days
20
Over 1 year

Leading Applicants

Applicants with the most 510(k) clearances or PMA approvals, trailing 365 days.

1Medtronic, Inc.231
2ABBOTT MEDICAL204
3Medtronic Neuromodulation90
4Boston Scientific Corporation80
5Boston Scientific Corp79
6Edwards Lifesciences, LLC74
7Medtronic Cardiac Rhythm Disease Management72
8Biotronik, Inc.65

Latest Authorizations

The ten most recent 510(k) clearances and PMA approvals.

NanoCeram Resin
3BFAB TEKNOLOJI A.S. — 510(k) K262681
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
Orthalign, Inc. — 510(k) K262253
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
Globus Medical, Inc. — 510(k) K262251
SnØreNegatØr
DnB Innovations, LLC — 510(k) K261912
xvision Spine system
Augmedics, Ltd. — 510(k) K261854
da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc. — 510(k) K261824
Vertiwedge® Intraosseous System
Foundation Surgical Group — 510(k) K261810
Interwedge® Standalone Lateral
Foundation Surgical Group — 510(k) K261809
Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)
Shanghai Hulu Devices Co., Ltd. — 510(k) K261494
LightStim for Wrinkles (1984); LightStim for Acne (2038)
Led Intellectual Properties, LLC — 510(k) K261482

About this data. Figures are drawn directly from the source and refresh on its own update schedule.