Atlas FDA

FOX

36 FDA 510(k) clearances · Product code

46 daysmedian time to decision
154 days90th percentile
36clearances measured

FDA profile

Official device name
Stand, Infusion
Device class
Class I (low risk)
Regulation
21 CFR 880.6990
Medical specialty
General Hospital
Adverse events (MAUDE)
2012: 5 · 2013: 7 · 2018: 17 · 2019: 23 · 2020: 112 · 2021: 173
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IV STANDS (K980336)Clinton Industries, Inc.1998-04-06
MEDRAD CONTRAST HOLDER (K964782)Medrad, Inc.1997-02-25
PORT-A-POLE (K961470)Prins Medical Ind., Inc.1996-07-22
HIGH VOLUME I.V. & IRRIGATION TOWER (K960027)Allen Medical Systems, Inc.1996-03-12
IV POLE/STAND (K952196)Valentine Intl. , Ltd.1995-07-31
IV SHUTTLE (K950367)Equipment Concepts, Inc.1995-04-26
STAND, INFUSION (K946201)Medical Specialties, Inc.1995-04-18
FLEXSYS MOBILEMATE EQUIPMENT STAND (K944580)Hill-Rom, Inc.1995-03-17
MOBILE CARE IV STAND (K932498)Mobile Care, Inc.1993-10-27
PNEUMATIC IRRIGATION STANDARD (K925066)Arthrodyn, Inc.1993-07-28
I.V. SKY-HOOK (K912010)Dina - Industria, Comercio E Exportacao , Ltd.1991-08-19
INTRAVENOUS STAND OR IV STAND (K900981)Travl-Med Infusion Device Transport System1990-03-27
AIV SYSTEMS' IV POLES (K895776)Automated IV Systems, Inc.1990-02-28
HYDRAULIC IV POLE (K893597)Arthro-Medic, Inc.1989-10-10
HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER (K883133)Ferguson Medical1988-11-21
CRITICAL CARE I.V. STAND STABILIZING BRACKET (K884341)Rbd Medical, Inc.1988-11-07
DITTMAR POWER LIFTER (K883260)Dittmar and Penn Corp.1988-11-07
ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE (K882493)Cambridge Technologies, Inc.1988-07-19
POLE, INTRAVENOUS (K880537)Ferguson Medical1988-04-06
TRACK AND CARRIER, INTRAVENOUS (K880538)Ferguson Medical1988-02-19
INFUSION STAND (K872729)Camtec1987-07-23
STAT-STAND(TM) AND STAT-STAND II(TM) (K870473)I.V. League Medical1987-02-13
FREE SPIRIT(TM) I.V. STAND (K864753)Demstar Corp.1987-01-20
POLYPOLE (K861838)Poly Medical Technologies, Inc.1986-06-09
UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE (K860468)Intl. Medication Systems, Ltd.1986-03-18
PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD (K854082)Gray Wave Corp.1985-11-01
THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K (K852937)Northern Customfab, Inc.1985-07-26
INOX IV STAND (K852300)Broadwest Corp.1985-06-20
STAND, OPERATING ROOM (K852329)Scholten Surgical Instruments, Inc.1985-06-14
KARECO INT'L - DOUGLE-HOOK I.V. STAND (K845031)Kareco Intl., Inc.1985-03-12
IMPACT 901 SERIES PORT-A-WALL (K850671)Impact Instrumentation, Inc.1985-03-11
BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEM (K850245)E.F. Brewer Co.1985-02-07
HEAVY-DUTY I.V. STAND (K823270)E.F. Brewer Co.1982-11-17
MAGUN BASE I.V. POLE (K821405)Manuco Manufacturing Co., Inc.1982-06-16
PATIENT PAL I.V. WALKER (K820963)Pryor Products1982-04-21
CATHETER, SURFLO, I.V. (K770422)Terumo America, Inc.1977-03-16

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Every clearance here is in the API, with alerts when new ones post.