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

Ipos Luneburg — Predicate Candidate Screening

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

32 daysmedian FDA review time

115 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K834143	NYLON COMPRESSION STUMP SHEATH	Ipos Luneburg	1984-01-09	39
K833868	IPOS G.L.P. SYSTEM	Ipos Luneburg	1983-11-28	21
K831690	IPOS ANTI-ADDUCTUS SHOE	Ipos Luneburg	1983-06-24	31
K802977	IPOCARBON STRETCH STOCKINETTE	Ipos Luneburg	1980-12-19	28
K802976	CARBONACRYL	Ipos Luneburg	1980-12-19	28
K800749	IPOCON 7	Ipos Luneburg	1980-07-28	115
K800716	ORTHOTIC LEG GAIT CORRECTOR DEVICE	Ipos Luneburg	1980-05-02	32
K800715	OHC DYNAMIC CLUB FOOT BRACE	Ipos Luneburg	1980-05-02	32

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