Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

PZP — Predicate Candidate Screening

9 FDA 510(k) clearances under this product code; the 50 most recent screened below.

162 daysmedian FDA review time
267 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDProcept Biorobotics2026-07-091260
K253211AQUABEAM Robotic SystemProcept Biorobotics2026-06-232670
K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HProcept Biorobotics2025-10-101840
K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics2024-09-30890
K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics2024-08-202080
K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation2023-08-301410
K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation2021-10-06290
K202961AquaBeam Robotic SystemProcept Biorobotics, Corporation2021-03-111620
DEN170024AQUABEAM SystemProcept Biorobotics, Corporation2017-12-212480

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