Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

FOX — Predicate Candidate Screening

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

46 daysmedian FDA review time

154 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K980336	IV STANDS	Clinton Industries, Inc.	1998-04-06	68
K964782	MEDRAD CONTRAST HOLDER	Medrad, Inc.	1997-02-25	90
K961470	PORT-A-POLE	Prins Medical Ind., Inc.	1996-07-22	96
K960027	HIGH VOLUME I.V. & IRRIGATION TOWER	Allen Medical Systems, Inc.	1996-03-12	70
K952196	IV POLE/STAND	Valentine Intl. , Ltd.	1995-07-31	83
K950367	IV SHUTTLE	Equipment Concepts, Inc.	1995-04-26	85
K946201	STAND, INFUSION	Medical Specialties, Inc.	1995-04-18	118
K944580	FLEXSYS MOBILEMATE EQUIPMENT STAND	Hill-Rom, Inc.	1995-03-17	179
K932498	MOBILE CARE IV STAND	Mobile Care, Inc.	1993-10-27	156
K925066	PNEUMATIC IRRIGATION STANDARD	Arthrodyn, Inc.	1993-07-28	295
K912010	I.V. SKY-HOOK	Dina - Industria, Comercio E Exportacao , Ltd.	1991-08-19	105
K900981	INTRAVENOUS STAND OR IV STAND	Travl-Med Infusion Device Transport System	1990-03-27	25
K895776	AIV SYSTEMS' IV POLES	Automated IV Systems, Inc.	1990-02-28	154
K893597	HYDRAULIC IV POLE	Arthro-Medic, Inc.	1989-10-10	154
K883133	HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER	Ferguson Medical	1988-11-21	118
K884341	CRITICAL CARE I.V. STAND STABILIZING BRACKET	Rbd Medical, Inc.	1988-11-07	24
K883260	DITTMAR POWER LIFTER	Dittmar and Penn Corp.	1988-11-07	96
K882493	ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE	Cambridge Technologies, Inc.	1988-07-19	33
K880537	POLE, INTRAVENOUS	Ferguson Medical	1988-04-06	57
K880538	TRACK AND CARRIER, INTRAVENOUS	Ferguson Medical	1988-02-19	10
K872729	INFUSION STAND	Camtec	1987-07-23	15
K870473	STAT-STAND(TM) AND STAT-STAND II(TM)	I.V. League Medical	1987-02-13	10
K864753	FREE SPIRIT(TM) I.V. STAND	Demstar Corp.	1987-01-20	46
K861838	POLYPOLE	Poly Medical Technologies, Inc.	1986-06-09	27
K860468	UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE	Intl. Medication Systems, Ltd.	1986-03-18	40
K854082	PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD	Gray Wave Corp.	1985-11-01	25
K852937	THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K	Northern Customfab, Inc.	1985-07-26	16
K852300	INOX IV STAND	Broadwest Corp.	1985-06-20	22
K852329	STAND, OPERATING ROOM	Scholten Surgical Instruments, Inc.	1985-06-14	14
K845031	KARECO INT'L - DOUGLE-HOOK I.V. STAND	Kareco Intl., Inc.	1985-03-12	75
K850671	IMPACT 901 SERIES PORT-A-WALL	Impact Instrumentation, Inc.	1985-03-11	19
K850245	BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEM	E.F. Brewer Co.	1985-02-07	16
K823270	HEAVY-DUTY I.V. STAND	E.F. Brewer Co.	1982-11-17	15
K821405	MAGUN BASE I.V. POLE	Manuco Manufacturing Co., Inc.	1982-06-16	36
K820963	PATIENT PAL I.V. WALKER	Pryor Products	1982-04-21	15
K770422	CATHETER, SURFLO, I.V.	Terumo America, Inc.	1977-03-16	9

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