See how long FDA took to clear devices like yours, and who got there first.
- Real review timesMedian calendar days from FDA receipt to clearance for your product code.
- Clearances per yearHow busy your code is, plus the companies that clear most often.
- Recent clearancesThe newest 510(k)s under your code, with links to read their summaries.
The short answer
Over the last 12 months a cleared 510(k), FDA’s premarket notification, took a median of 132 calendar days from receipt to clearance, across 3,183 clearances. Among the 30 busiest product codes, the median ran from 57 to 254 days.
How it works
- Enter your product codeThree letters, such as DQA for an oximeter, or a few words about the device.
- We read every clearanceAll cleared 510(k)s under that code since 2021, from FDA’s own database.
- You see the real timelineMedian days, the spread, clearances per year and the most recent files.
The 30 product codes with the most 510(k) clearances in the last 12 months
| # | Product code | Device | Class | 510(k)s cleared | Median days |
|---|---|---|---|---|---|
| 1 | QIH | Automated Radiological Image Processing Software | II | 94 | 138.5 |
| 2 | GEX | Powered Laser Surgical Instrument | II | 76 | 88 |
| 3 | HRS | Plate, Fixation, Bone | II | 60 | 84.5 |
| 4 | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | II | 58 | 117 |
| 5 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | II | 49 | 176 |
| 6 | LLZ | System, Image Processing, Radiological | II | 49 | 110 |
| 7 | OLO | Orthopedic Stereotaxic Instrument | II | 49 | 110 |
| 8 | HGX | Pump, Breast, Powered | II | 40 | 135 |
| 9 | ITI | Wheelchair, Powered | II | 39 | 108 |
| 10 | OHS | Light Based Over The Counter Wrinkle Reduction | II | 36 | 88 |
| 11 | NKB | Thoracolumbosacral Pedicle Screw System | II | 35 | 88 |
| 12 | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | II | 32 | 64 |
| 13 | NHA | Abutment, Implant, Dental, Endosseous | II | 32 | 142.5 |
| 14 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | II | 31 | 148 |
| 15 | GCJ | Laparoscope, General & Plastic Surgery | II | 29 | 123 |
| 16 | DQK | Computer, Diagnostic, Programmable | II | 28 | 126.5 |
| 17 | LNH | System, Nuclear Magnetic Resonance Imaging | II | 28 | 126 |
| 18 | INI | Vehicle, Motorized 3-Wheeled | II | 24 | 108.5 |
| 19 | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | II | 24 | 125.5 |
| 20 | QJP | Catheter, Percutaneous, Neurovasculature | II | 24 | 141.5 |
| 21 | HWC | Screw, Fixation, Bone | II | 22 | 120.5 |
| 22 | IOR | Wheelchair, Mechanical | I | 21 | 99 |
| 23 | JAK | System, X-Ray, Tomography, Computed | II | 21 | 156 |
| 24 | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | II | 21 | 92 |
| 25 | DZE | Implant, Endosseous, Root-Form | II | 20 | 201.5 |
| 26 | OWB | Interventional Fluoroscopic X-Ray System | II | 20 | 208.5 |
| 27 | DYB | Introducer, Catheter | II | 19 | 59 |
| 28 | EBF | Material, Tooth Shade, Resin | II | 19 | 57 |
| 29 | FRO | Dressing, Wound, Drug | Unclassified | 19 | 254 |
| 30 | HSB | Rod, Fixation, Intramedullary And Accessories | II | 19 | 119 |
These are calendar days, so they include the weeks a file sits on hold while the company answers FDA’s questions. FDA counts its own review in FDA days, which our 510(k) review time page explains. The tool leaves out the time before you submit (usually the longer part), third party review, De Novo and PMA files, and 510(k)s that were not cleared.
What OVA does here, and where our responsibility ends
We design the electronics, firmware and mechanics of medical devices and take them from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
The result is an orientation, not a regulatory opinion. Confirm the pathway, the predicate and the timeline with a regulatory specialist or through a Pre-Submission (Q-Sub) with FDA. The tool runs in your browser. Your answers are not sent to us; with your cookie consent, Google Analytics records only that the tool was used and the category of the result.
Questions
How long does a 510(k) take in 2026?
Over the last 12 months the middle half of cleared 510(k)s took 83 to 226 calendar days; the time depends on the product code.
Why is the calendar time longer than FDA’s 90-day goal?
FDA’s goal is a decision on 95% of 510(k)s within 90 FDA days; its clock stops while it waits for the company’s answers. For 510(k)s received in FY2025 that company time averaged 66 days, against 76 FDA days.
Can I use a recent clearance as my predicate?
Maybe. A predicate needs the same intended use, and differences in technology must not raise different questions of safety and effectiveness.
What is a Special 510(k)?
A 510(k) for a change to the company’s own cleared device, reviewed on a shorter timeline. Over the last 12 months 14.6% of cleared 510(k)s were Special.
Related pages
Sources
Data as of October 12, 2026. By Lisa Voronkova, CEO of OVA Solutions. Updated on October 22, 2026.