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

Mcconnell Orthopedic — Predicate Candidate Screening

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

15 daysmedian FDA review time

71 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K910974	MCCONNELL SHOULDER BRACE	Mcconnell Orthopedic	1991-03-21	14
K905564	PREP AND OPERATING STAND	Mcconnell Orthopedic	1991-02-21	71
K905565	LATERAL BUTTRESS SUPPORT	Mcconnell Orthopedic	1991-02-21	71
K885100	MCCONNELL REAMER GUIDE	Mcconnell Orthopedic	1989-01-13	32
K871823	MCCONNELL ORTHOPEDIC TIBIAL POSITIONER	Mcconnell Orthopedic	1987-05-26	15
K871820	MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT	Mcconnell Orthopedic	1987-05-26	15
K871822	MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY	Mcconnell Orthopedic	1987-05-26	15
K871821	MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT	Mcconnell Orthopedic	1987-05-26	15
K871824	MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM	Mcconnell Orthopedic	1987-05-26	15
K871839	MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT	Mcconnell Orthopedic	1987-05-26	14
K871840	MCCONNELL ORTHOPEDIC ANKLE POSITIONER	Mcconnell Orthopedic	1987-05-26	14
K871819	MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER	Mcconnell Orthopedic	1987-05-22	11
K871703	MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM	Mcconnell Orthopedic	1987-05-19	18
K871803	MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP)	Mcconnell Orthopedic	1987-05-19	11
K871805	MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT	Mcconnell Orthopedic	1987-05-19	11
K871804	MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY	Mcconnell Orthopedic	1987-05-19	11

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