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

Neocis, Inc. — Predicate Candidate Screening

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

115 daysmedian FDA review time

287 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K252376	Yomi S Robotic System	Neocis, Inc.	2025-10-28	90
K251835	Yomi Robotic System	Neocis, Inc.	2025-10-10	116
K231018	Yomi Robotic System	Neocis, Inc.	2023-08-14	126
K222750	Yomi Robotic System	Neocis, Inc.	2022-12-08	87
K222049	Yomi Robotic System	Neocis, Inc.	2022-11-04	115
K211466	Yomi Robotic System with YomiPlan Go	Neocis, Inc.	2022-06-14	399
K210711	Neocis Guidance System (NGS) with Yomi Plan v2.0.1	Neocis, Inc.	2021-12-22	287
K211129	Neocis Guidance System (NGS) with Intraoral Fiducial Array	Neocis, Inc.	2021-07-28	103
K203401	Neocis Guidance System (NGS) with Patient Splints (EPS)	Neocis, Inc.	2020-12-15	26
K202264	Neocis Guidance System (NGS) with Yomi Plan v2.0	Neocis, Inc.	2020-12-04	115
K202100	Neocis Guidance System (NGS) with Clamped Chairside Patient	Neocis, Inc.	2020-10-19	82
K200805	Neocis Guidance System (NGS) with Patient Splints	Neocis, Inc.	2020-07-28	123
K200348	Neocis Guidance System (NGS) with Fiducial Array Splint (FAS	Neocis, Inc.	2020-05-08	86
K191363	Neocis Planning Software Application (NPSA) for 3rd Party PC	Neocis, Inc.	2019-10-02	133
K191605	Neocis Guidance System (NGS)	Neocis, Inc.	2019-09-11	86
K182776	Neocis Guidance System	Neocis, Inc.	2018-12-21	81
K173402	Neocis Guidance System (NGS) with Chairside Splint	Neocis, Inc.	2018-02-22	114
K161399	Neocis Guidance System	Neocis, Inc.	2016-12-22	216

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