Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

CenterPoint Systems, LLC — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

62 daysmedian FDA review time
304 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC2026-07-29620
K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC2026-07-29280
K261492FieldFlex Steerable SheathCenterPoint Systems, LLC2026-06-05300
K260942AuST Steerable SheathCenterPoint Systems, LLC2026-04-07180
K260163AuST CSP IntroducerCenterPoint Systems, LLC2026-02-19300
K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC2025-06-271000
K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC2025-06-181180
K251051AuST Steerable SheathCenterPoint Systems, LLC2025-04-30270
K243180SSPC NXT Delivery CatheterCenterPoint Systems, LLC2024-12-04650
K242106AuST Steerable SheathCenterPoint Systems, LLC2024-10-04780
K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital ContCenterPoint Systems, LLC2024-05-021620
K240829AuST Steerable SheathCenterPoint Systems, LLC2024-05-01360
K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC2023-07-313040
K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC2023-03-09270
K210009Guiding CatheterCenterPoint Systems, LLC2021-11-243240

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda