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

FHC, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time

206 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231141	STarFix Designer Software C0265	FHC, Inc.	2023-09-08	140	0
K200169	VFS1 Bipolar Electrosurgical Generator	FHC, Inc.	2020-05-14	112	0
K183123	microTargeting Guideline 4000 5.0 System	FHC, Inc.	2018-12-20	37	0
K121950	MICROTARGETING XL STAR DRIVE SYSTEM	FHC, Inc.	2012-07-26	23	0
K092192	WAYPOINT STEREOTACTIC SYSTEM	FHC, Inc.	2010-02-12	206	0
K092562	MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS	FHC, Inc.	2009-09-18	29	2
K071364	MICROTARGETING GUIDELINE 4000	FHC, Inc.	2007-07-25	70	1
K033173	MICRO TARGETING ELECTRODE	FHC, Inc.	2004-03-24	175	0
K011775	MICRO TARGETING DRIVE SYSTEM	FHC, Inc.	2001-08-30	84	2
K011992	FHC MICROTARGETING DRIVE SYSTEM	FHC, Inc.	2001-08-14	49	4
K003776	MICROTARGETING DRIVE SYSTEM	FHC, Inc.	2001-02-23	78	4
K991522	MICROTARGETING ELECTRODE	FHC, Inc.	2000-08-04	459	3

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