Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Ohio Medical Instrument Co., Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time

224 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021604	MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020	Ohio Medical Instrument Co., Inc.	2002-07-29	74	1
K013428	MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL AC	Ohio Medical Instrument Co., Inc.	2002-04-04	170	0
K992843	THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SUR	Ohio Medical Instrument Co., Inc.	1999-11-02	70	0
K991267	SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND	Ohio Medical Instrument Co., Inc.	1999-07-12	90	0
K983282	OMI OCCIPITAL CERVICAL LOOP, MODEL A1089	Ohio Medical Instrument Co., Inc.	1998-11-19	62	0
K982244	MAYFIELD ACCISS OPTICAL SYSTEM	Ohio Medical Instrument Co., Inc.	1998-09-23	90	0
K960807	TEW CRANIAL/SPINAL RETRACTOR MODEL A1090	Ohio Medical Instrument Co., Inc.	1996-05-17	79	0
K953124	MAYFIELD RADIOLUCENT 2000 SKULL CLAMP	Ohio Medical Instrument Co., Inc.	1996-02-09	219	0
K941558	MAYFIELD CHILD DISPOSABLE SKULL PIN	Ohio Medical Instrument Co., Inc.	1995-12-06	615	0
K934289	MAYFIELD RADIOLUCENT SKULL CLAMP	Ohio Medical Instrument Co., Inc.	1994-01-07	127	0
K932807	MAYFIELD* A-2000 SKULL CLAMP	Ohio Medical Instrument Co., Inc.	1993-09-28	111	0
K932860	MAYFIELD ADULT DISPOSABLE SKULL PIN	Ohio Medical Instrument Co., Inc.	1993-09-28	109	0
K923789	MAYFIELD ADULT DISPOSABLE SKULL PIN	Ohio Medical Instrument Co., Inc.	1993-02-12	199	0
K902077	T19S BIOPSY NEEDLE	Ohio Medical Instrument Co., Inc.	1990-07-27	80	0
K882544	CUDDLE UP PILLOW	Ohio Medical Instrument Co., Inc.	1989-01-31	224	0
K851021	MAYFIELD TABLE-ELECTRIC	Ohio Medical Instrument Co., Inc.	1985-05-21	70	0
K851022	SINGLE LEG MAYFIELD TABLE	Ohio Medical Instrument Co., Inc.	1985-04-17	36	0
K837028	PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHY	Ohio Medical Instrument Co., Inc.	1983-03-09	89	0
K830332	BUDDE-HALO RETRACTOR	Ohio Medical Instrument Co., Inc.	1983-03-02	29	1

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