MO
Maya Okafor
Chief executive
Reviews what the agents draft each morning
Find your predicate. Trace the whole chain.
Name your device and we walk its product code back through every cleared predicate to the device that was on the market before the 1976 amendments.
Choose the pathway. See the calendar it sets.
510(k), De Novo or PMA. Each sets an FDA review goal, the evidence you need and what you can claim on the label.
Check your freedom to operate.
We place your claims among the patents filed in your classes, and flag the ones that sit close enough to read in full before you build.
Plan the trial. Learn from the ones recruiting.
See what similar device studies enroll, where their sites are and what they measure, before you write your protocol.
Get paid for it. Code, coverage, rate.
A cleared device still needs a code, a coverage decision and a payment rate. We trace each one from the codes your peers already bill.
Launch where the procedures happen.
Rank hospitals and physicians by how often they do the procedure, see who already works with your competitors, and staff the first accounts.
Predicate chain
Your device
Class II · the product code you name
Its predicate
Cleared through a 510(k) in the same code
The predicate’s predicate
Substantially equivalent, one step back
A device sold before 28 May 1976
Where the chain of equivalence starts
Review goals in FDA days
510(k)
90 days
De Novo
150 days
PMA
180 days
Since 1 August our records hold 599 510(k) decisions. A 510(k) needs a predicate in your product code, and most need no clinical study.
Patent field
Example
Your claims
Read in full
Nearby
Same classes
Device trials recruiting now
Tinnitus
NCT07885176
60 participants planned
Obesity, BMI over 35
NCT07884994
50 participants planned
Rotator cuff disease
NCT07886827
40 participants planned
Anxiety and pain in children under anesthesia
NCT07886333
40 participants planned
From procedure to payment
Procedure
What the physician does with your device
Code
A CPT or HCPCS code that describes it
Coverage
A national or local coverage decision
Rate
The fee schedule amount per setting
New technology add-on. If your device is new and costly, an inpatient add-on payment can bridge the gap.
First accounts
Example
1
Academic medical centre, Midwest
1,240
2
Regional heart institute, Southeast
1,105
3
Integrated health system, West
930
4
Community hospital network, Northeast
760
5
Ambulatory surgery centre group, Texas
610
6
Teaching hospital, Mid-Atlantic
540
Procedures a year in the example. Your list comes from Medicare provider volume and Open Payments.