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

FTY · Predicate Candidate Screening

23 FDA 510(k) clearances under this product code; the 50 most recent screened below.

31 daysmedian FDA review time

80 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K160501	Noxilizer Surgical Ruler	Noxilizer, Inc.	2016-05-26	93
K951064	DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, P	S-E Sales & Distribution, Inc.	1995-05-19	72
K934930	OLYMPIC AUTO-LENGTH	Olympic Medical Corp.	1993-12-29	76
K932112	OLYMPIC INFA-LENGTH	Olympic Medical Corp.	1993-07-22	80
K883485	STRYKER PRESSURE MONITOR SYSTEM	Stryker Corp.	1988-09-13	28
K880441	PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.	Plane Iii, Inc.	1988-02-18	16
K874352	TUMORIMETER	Cancer Technologies, Inc.	1987-11-23	31
K873470	TEMPLATE	Cox-Uphuff Intl.	1987-09-08	11
K872319	LN 100 BREAST MARKER	Instrumentation Industries, Inc.	1987-08-11	55
K863409	KUNDIN WOUND GAUGE	Jane I. Kundin	1986-09-29	26
K862576	PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)	Professional Services For Surgeons, Ltd.	1986-07-15	8
K860912	PS2 BRAND MAMMAPLASTY	Professional Services For Surgeons, Ltd.	1986-03-24	13
K854892	RULER	Euro-Med Intl.	1985-12-24	18
K840651	MOLE-MARKER	Notation Systems, Inc.	1984-03-12	26
K832899	ZIMMER OSSIMETER	Zimmer, Inc.	1983-10-14	46
K831041	SAGITTAL KNEE TESTER	Orthopedic Systems, Inc.	1983-06-24	85
K812713	DRAWER TEST	Medmetric Corp.	1981-11-05	41
K812069	BORES* DEPTH GAUGE	Santa Barbara Medco, Inc.	1981-08-31	41
K811278	EXTENDED TUMOR CALIPER	Mick Radio-Nuclear Instruments, Inc.	1981-06-02	25
K801939	RHYTIDOMETER	Aztec Medical Products, Inc.	1980-09-26	45
K801374	PROXIMATE (TMD) TISSUE MEASURING DEVICE	ETHICON, Inc.	1980-06-26	16
K790660	SURGICAL RULER	Richard-Allan Medical Ind., Inc.	1979-04-12	10
K790089	TAPE MEASURE	Pfizer, Inc.	1979-03-06	48

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