Product Code: FOX
FDA class 1
21 CFR 880.6990
Stand, Infusion
General Hospital
The Infusion Stand is a wheeled or floor-mounted pole used in clinical settings to suspend intravenous bags, infusion pumps, and other hanging medical equipment during patient fluid therapy. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FOX, regulated under 21 CFR 880.6990 in the General Hospital specialty.
510(k)s
36
FEI Numbers
290
Registration Numbers
290
Unique Applicants
33
Years Active
21
Basic Information
- Product Code
- FOX
- Device Class
- FDA class 1
- Regulation Number
- 880.6990
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 36 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K980336 | IV STANDS | Apr 06, 1998 | Substantially Equivalent | CLINTON INDUSTRIES, INC. |
| K964782 | MEDRAD CONTRAST HOLDER | Feb 25, 1997 | Substantially Equivalent | MEDRAD, INC. |
| K961470 | PORT-A-POLE | Jul 22, 1996 | Substantially Equivalent | PRINS MEDICAL IND., INC. |
| K960027 | HIGH VOLUME I.V. & IRRIGATION TOWER | Mar 12, 1996 | Substantially Equivalent | ALLEN MEDICAL SYSTEMS, INC. |
| K952196 | IV POLE/STAND | Jul 31, 1995 | Substantially Equivalent | VALENTINE INTL. LTD. |
| K950367 | IV SHUTTLE | Apr 26, 1995 | Substantially Equivalent | EQUIPMENT CONCEPTS, INC. |
| K946201 | STAND, INFUSION | Apr 18, 1995 | Substantially Equivalent | MEDICAL SPECIALTIES, INC. |
| K944580 | FLEXSYS MOBILEMATE EQUIPMENT STAND | Mar 17, 1995 | Substantially Equivalent | HILL-ROM, INC. |
| K932498 | MOBILE CARE IV STAND | Oct 27, 1993 | Substantially Equivalent | MOBILE CARE, INC. |
| K925066 | PNEUMATIC IRRIGATION STANDARD | Jul 28, 1993 | Substantially Equivalent | ARTHRODYN, INC. |
| K912010 | I.V. SKY-HOOK | Aug 19, 1991 | Substantially Equivalent | DINA - INDUSTRIA, COMERCIO E EXPORTACAO LTD. |
| K900981 | INTRAVENOUS STAND OR IV STAND | Mar 27, 1990 | Substantially Equivalent | TRAVL-MED INFUSION DEVICE TRANSPORT SYSTEM |
| K895776 | AIV SYSTEMS' IV POLES | Feb 28, 1990 | Substantially Equivalent | AUTOMATED IV SYSTEMS, INC. |
| K893597 | HYDRAULIC IV POLE | Oct 10, 1989 | Substantially Equivalent | ARTHRO-MEDIC, INC. |
| K883133 | HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER | Nov 21, 1988 | Substantially Equivalent | FERGUSON MEDICAL |
| K884341 | CRITICAL CARE I.V. STAND STABILIZING BRACKET | Nov 07, 1988 | Substantially Equivalent | RBD MEDICAL, INC. |
| K883260 | DITTMAR POWER LIFTER | Nov 07, 1988 | Substantially Equivalent | DITTMAR AND PENN CORP. |
| K882493 | ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE | Jul 19, 1988 | Substantially Equivalent | CAMBRIDGE TECHNOLOGIES, INC. |
| K880537 | POLE, INTRAVENOUS | Apr 06, 1988 | Substantially Equivalent | FERGUSON MEDICAL |
| K880538 | TRACK AND CARRIER, INTRAVENOUS | Feb 19, 1988 | Substantially Equivalent | FERGUSON MEDICAL |
| K872729 | INFUSION STAND | Jul 23, 1987 | Substantially Equivalent | CAMTEC |
| K870473 | STAT-STAND(TM) AND STAT-STAND II(TM) | Feb 13, 1987 | Substantially Equivalent | I.V. LEAGUE MEDICAL |
| K864753 | FREE SPIRIT(TM) I.V. STAND | Jan 20, 1987 | Substantially Equivalent | DEMSTAR CORP. |
| K861838 | POLYPOLE | Jun 09, 1986 | Substantially Equivalent | POLY MEDICAL TECHNOLOGIES, INC. |
| K860468 | UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE | Mar 18, 1986 | Substantially Equivalent | INTL. MEDICATION SYSTEMS, LTD. |
| K854082 | PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD | Nov 01, 1985 | Substantially Equivalent | GRAY WAVE CORP. |
| K852937 | THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K | Jul 26, 1985 | Substantially Equivalent | NORTHERN CUSTOMFAB, INC. |
| K852300 | INOX IV STAND | Jun 20, 1985 | Substantially Equivalent | BROADWEST CORP. |
| K852329 | STAND, OPERATING ROOM | Jun 14, 1985 | Substantially Equivalent | SCHOLTEN SURGICAL INSTRUMENTS, INC. |
| K845031 | KARECO INT'L - DOUGLE-HOOK I.V. STAND | Mar 12, 1985 | Substantially Equivalent | KARECO INTL., INC. |
| K850671 | IMPACT 901 SERIES PORT-A-WALL | Mar 11, 1985 | Substantially Equivalent | IMPACT INSTRUMENTATION, INC. |
| K850245 | BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEM | Feb 07, 1985 | Substantially Equivalent | E.F. BREWER CO. |
| K823270 | HEAVY-DUTY I.V. STAND | Nov 17, 1982 | Substantially Equivalent | E.F. BREWER CO. |
| K821405 | MAGUN BASE I.V. POLE | Jun 16, 1982 | Substantially Equivalent | MANUCO MANUFACTURING CO., INC. |
| K820963 | PATIENT PAL I.V. WALKER | Apr 21, 1982 | Substantially Equivalent | PRYOR PRODUCTS |
| K770422 | CATHETER, SURFLO, I.V. | Mar 16, 1977 | Substantially Equivalent | TERUMO AMERICA, INC. |
FEI Numbers
This FDA classification entry is associated with 290 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 290 registration numbers. Click on an entry to view related FDA registrations.