510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Flow Cytometric Test System For Hematopoietic Neoplasms
Hematology
The Flow Cytometric Test System For Hematopoietic Neoplasms is a hematology in vitro diagnostic device consisting of reagents intended for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer, used as an aid in the differential diagnosis of patients with or suspected of having hematopoietic neoplasms including chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms. It is classified as FDA Class II under regulation 21 CFR 864.7010, requiring 510(k) clearance and compliance with general and special controls, and is eligible for third-party review. The product code is PWD and it falls under the Hematology medical specialty. It is not flagged as an implant or life-sustaining device.
510(k) Clearances
2 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.