Device class (I / II / III) — the regulator's risk tier. I = low risk (e.g. bandages, exam gloves); II = moderate risk and the bulk of devices (e.g. infusion pumps, catheters); III = highest risk / life-sustaining (e.g. implantable defibrillators, heart valves).
510(k) — the most common US market-authorisation route: the maker shows the device is “substantially equivalent” to one already on the market, without a full clinical trial.
PMA (Premarket Approval) — the strictest route, reserved for high-risk Class III devices; it requires clinical evidence of safety and effectiveness.
“510(k)/PMA on file” — the share of devices that carry one of these official authorisation numbers, i.e. that went through a documented regulatory review.
Device type (nomenclature) — a standardised international label for “what kind of device this is” (e.g. peripheral angioplasty balloon catheter), used here as the market unit.
HCPCS code — the billing code the public payer uses to pay for a device or supply; one code can cover many brands and manufacturers.
Durable medical equipment fee schedule — Medicare's official price list (allowed amounts) for durable medical equipment, prosthetics, orthotics & supplies — the closest thing to a “reimbursed price” for devices.
Submitted vs Allowed vs Paid — three different prices for the same code. Submitted = the “sticker” price the provider bills (inflated, almost never the real price). Allowed = the price the payer actually recognises = the real transacted price (split between the payer and the patient). Paid = the part the payer itself pays (for Medicare, ~80% of allowed; the patient/secondary insurer covers the rest). So submitted ≥ allowed ≥ paid, and Allowed is the one to track.
Whose prices? (Medicare only) — all prices in the analytics, reimbursement & geography modules are Medicare fee-for-service (the public administered fee schedule). Medicaid (state-set, usually lower), commercial/private insurers (negotiated, usually higher — often 150–300% of Medicare) and the VA (its own national contracts) pay different amounts and are not in this feed. The only place you see negotiated private-payer prices is the Hospital pricing module (hospital price-transparency files, by insurer).
Implantable = placed inside the body; single-use = disposable; combination product = a device that also delivers a drug (e.g. a drug-eluting stent, a pre-filled auto-injector) — the bridge to the prescription block.