Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: FPO FDA class 2

Stretcher, Wheeled

General Hospital

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The Wheeled Stretcher is a mobile patient transport device equipped with wheels, used to move patients within a healthcare facility between departments, examination rooms, operating suites, or emergency areas. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPO, regulated under 21 CFR 880.6910 in the General Hospital specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K113598

POWER-LOAD COT FASTENER SYSTEM

Dec 20, 2011

Substantially Equivalent

STRYKER MEDICAL

K072598

IRSG I-MOVER FOR BEDS

Apr 14, 2008

Substantially Equivalent

INTERNATIONAL RETAIL SERVICES GROUP, LLC

K972528

DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)

Jul 28, 1997

Substantially Equivalent

DYNA CORP.

K955766

ADULT-PEDIATRIC TRANSPORT SYSTEM

Aug 07, 1996

Substantially Equivalent

INTERNATIONAL BIOMEDICAL, INC.

K962181

HARE MODEL 2000 EZ LOADER MODEL 95555

Aug 01, 1996

Substantially Equivalent

DYNA CORP.

K961437

WHEELED STRETCHER

Jun 03, 1996

Substantially Equivalent

HILL-ROM, INC.

K952447

HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER

Nov 22, 1995

Substantially Equivalent

HILL-ROM, INC.

K946101

EMERGENCY/ACCIDENT TROLLEY 550

Feb 07, 1995

Substantially Equivalent

HOGAN & HARTSON

K945431

MODEL 792 CONVERGE, MODEL 793 VISION 2000

Jan 25, 1995

Substantially Equivalent

HAUSTED, INC.

K943969

MODEL 578 MOBILE SURGICAL STRETCHER

Jan 25, 1995

Substantially Equivalent

HAUSTED, INC.

K942948

STRYKER POWERED STRETCHER

Jan 24, 1995

Substantially Equivalent

STRYKER CORP.

K943528

PATIENT TROLLEY 545

Oct 04, 1994

Substantially Equivalent

MERIVAARA INSTRUMENTARIUM CORP.

K943529

PATIENT TROLLEY 540

Oct 04, 1994

Substantially Equivalent

MERIVAARA INSTRUMENTARIUM CORP.

K943262

FUTURA JUNIOR 300/310

Sep 29, 1994

Substantially Equivalent

MERIVAARA INSTRUMENTARIUM CORP.

K943864

STRYKER 8000 SURGERY STRETCHER

Aug 25, 1994

Substantially Equivalent

STRYKER MEDICAL

K935297

STRYKER AMBULANCE COT MODEL 6060

Feb 18, 1994

Substantially Equivalent

STRYKER MEDICAL

K923730

MODEL 561 C-ARM PROCEDURES STRETCHER

Feb 09, 1994

Substantially Equivalent

MIDMARK CORP.

K933060

S-610 & 2-628 WHEELED SHOWER STRETCHERS

Feb 04, 1994

Substantially Equivalent

THE ANTHROS MEDICAL GROUP

K933071

STS 701 TRANSPORT STRETCHER

Jan 26, 1994

Substantially Equivalent

WY'EAST MEDICAL CORP.

K933366

I.V. LINK

Jan 10, 1994

Substantially Equivalent

DEVILLE LABORATORIES, INC.

K932260

FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE

Sep 09, 1993

Substantially Equivalent

FERNO

K922809

GENERAL PROCEDURAL STRETCHERS (P880- P886)

Mar 31, 1993

Substantially Equivalent

HILL-ROM, INC.

K922808

HILL-ROM VIA STRETCHER (P1300 - P1303)

Mar 31, 1993

Substantially Equivalent

HILL-ROM, INC.

K920704

STRYKER I.V. CADDY ACCESSORY DEVICE

Mar 23, 1992

Substantially Equivalent

STRYKER MEDICAL

K914543

ST5500 UNIVERSAL CARE STRETCHER

Jan 08, 1992

Substantially Equivalent

LIC CARE, INC.

K904011

MODEL #527 OPHTHALMIC STRETCHER

Oct 03, 1990

Substantially Equivalent

MIDMARK CORP.

K902503

HARE FOLDING BACK EMERGENCY STRETCHER

Jun 26, 1990

Substantially Equivalent

DYNA CORP.

K900872

WHEELED STRETCHER

May 18, 1990

Substantially Equivalent

HOSPITAL SUPPLY CO., INC.

K895740

SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART

Feb 22, 1990

Substantially Equivalent

LUMEX, INC.

K884759

SHOWER STRETCHER W/WHEELS

Jun 15, 1989

Substantially Equivalent

LINIDO, INC.

K881845

HARE ANY LEVEL COT

Jun 03, 1988

Substantially Equivalent

DYNA INDUSTRIES, INC.

K874332

MRI STRETCHER

Jan 05, 1988

Substantially Equivalent

ATOMIC PRODUCTS CORP.

K873181

STRETCHER, WHEELED, MECHANICAL

Oct 09, 1987

Substantially Equivalent

CAMBRIDGE TECHNOLOGIES, INC.

K871556

MERIVAARA EMERGENCY PATIENT TROLLEY #436

Apr 30, 1987

Substantially Equivalent

GLOBAL MEDICAL PRODS, INC.

K864269

MODEL 35-B ALL LEVEL COT

Nov 13, 1986

Substantially Equivalent

FERNO-WASHINGTON, INC.

K862959

MERIVAARA PATIENT TROLLEY - MODEL #416

Sep 25, 1986

Substantially Equivalent

GLOBAL MEDICAL PRODS, INC.

K862441

EZ LOAD MODEL 30, ALL LEVEL COT

Sep 12, 1986

Substantially Equivalent

FERNO-WASHINGTON, INC.

K863083

BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER

Sep 03, 1986

Substantially Equivalent

BETA MEDICAL PRODUCTS CO.

K861410

LIC MOBILE TRANSPORT STRETCHERS

Apr 22, 1986

Substantially Equivalent

LADA INTL., INC.

K854304

KEYMED OFFICE COUCH

Nov 12, 1985

Substantially Equivalent

KEYMED, INC.

K853421

THE KEYMED VARI-HEIGHT PATIENT COUCH

Sep 19, 1985

Substantially Equivalent

KEYMED, INC.

K844578

NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA

May 14, 1985

Substantially Equivalent

ENGINEERING DYNAMICS CORP.

K843439

CENTURIAN HYDRAULIC STRETCHER

Sep 13, 1984

Substantially Equivalent

AMERICAN STERILIZER CO.

K840920

KEYMED MOBILE ENDOSCOPY PATIENT COUCH

Mar 19, 1984

Substantially Equivalent

KEYMED, INC.

K840122

IURA AMBULANCE STRETCHER IAS-1

Jan 27, 1984

Substantially Equivalent

TRADE WEST, INC.

K840124

IURA UNIVERSAL HOSPITAL STRETCHER-HS-13

Jan 27, 1984

Substantially Equivalent

TRADE WEST, INC.

K840125

IURA UNIVERSAL WHEELCHAIR/STRETCHER-

Jan 27, 1984

Substantially Equivalent

TRADE WEST, INC.

K801935

PAD, HOSPITAL STRETCHER

Aug 27, 1980

Substantially Equivalent

VOLUNTEER BLIND INDUSTRIES, INC.

K792570

PATIENT TROLLEY B49

Dec 31, 1979

Substantially Equivalent

ETS RENE MARZET

K761147

RELIANCE MOD-U-LINE M-700

Jan 28, 1977

Substantially Equivalent

F. & F. KOENIGKRAMER

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

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