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

OUP — Predicate Candidate Screening

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

86 daysmedian FDA review time

620 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232153	Avéli	Revelle Aesthetics, Inc.	2023-08-18	30	0
K221336	Avéli	Revelle Aesthetics, Inc.	2022-08-05	88	0
K212399	Aveli	Nc8, Inc.	2021-10-22	81	0
K192185	The Cellfina System	Ulthera, Inc.	2019-10-09	58	0
K161885	The Cellfina System	Ulthera, Inc.	2016-10-05	86	1
K153677	The Cellfina System	Ulthera, Inc.	2016-02-25	66	0
K150505	Cellfina System	Ulthera, Inc.	2015-07-29	154	0
K134010	CABOCHON SYSTEM	Cabochon Aesthetics, Inc.	2014-04-14	105	0
DEN110004	CABOCHON SYSTEM	Cabochon Aesthetics, Inc.	2013-07-12	620	0

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