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

Flexmedics — Predicate Candidate Screening

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

56 daysmedian FDA review time

229 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K990765	FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK	Flexmedics	1999-03-15	7
K964955	FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK	Flexmedics	1997-02-14	65
K952430	FINESSE GUIDEWIRE CORONARY	Flexmedics	1995-08-18	86
K943390	FLEXFINDER GUIDEWIRE	Flexmedics	1995-06-27	348
K942074	FLEXFINDER GUIDEWIRE	Flexmedics	1994-06-24	56
K934265	FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE	Flexmedics	1994-01-21	143
K912843	FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE	Flexmedics	1991-09-24	90
K910674	FLEXMEDICS MALLEABLE CANNULA	Flexmedics	1991-04-12	56
K895899	FLEXMEDICS GUIDEWIRE .012 ONLY	Flexmedics	1990-05-23	229
K893626	FLEXMEDICS GUIDEWIRE	Flexmedics	1989-09-26	138
K885086	TIN COATED NITI ORTHODONTIC ARCH WIRES	Flexmedics	1989-01-10	32
K883120	FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE	Flexmedics	1988-11-14	111
K881331	ORTHODONTIC NITINOL SPRINGS	Flexmedics	1988-04-21	23
K881233	STRAIGHT LENGTH ARCH WIRES	Flexmedics	1988-04-12	21
K881274	CENTER BEND ARCH WIRES	Flexmedics	1988-04-12	18
K880882	REVERSE CURVE ARCHWIRE	Flexmedics	1988-04-11	39
K881163	RECTANGULAR NITINOL ARCH WIRE	Flexmedics	1988-04-07	20
K873649	FLEX GOLD	Flexmedics	1987-10-05	26
K870156	FLEXMEDICS NITINOL MAMMORY WIRE	Flexmedics	1987-02-24	42
K863742	FLEXMEDICS NITINOL ARCH WIRE	Flexmedics	1986-11-24	62

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