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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: KZI FDA class 1

Culture Media, Enriched

Microbiology

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The Enriched Culture Media is a laboratory reagent consisting of a nutrient-supplemented growth medium used to support the cultivation of fastidious or slow-growing microorganisms from clinical specimens, facilitating their identification in microbiology diagnostics. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KZI, regulated under 21 CFR 866.2330, in the Microbiology medical specialty. No special flags apply to this device.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)

Oct 25, 1988

Substantially Equivalent

OXOID U.S.A., INC.

DIAMOND'S MEDIUM MODIFIED

Jun 02, 1988

Substantially Equivalent

REMEL CO.

MIDDLEBROOK 7H9 BROTH

Mar 31, 1988

Substantially Equivalent

HARDY MEDIA

LOWENSTEIN-JENSEN, GRUFT

Mar 31, 1988

Substantially Equivalent

HARDY MEDIA

MIDDLEBROOK 7H11 AGAR

Mar 31, 1988

Substantially Equivalent

HARDY MEDIA

CYSTINE TRYPTIC MEDIUM BASE

Mar 30, 1988

Substantially Equivalent

HARDY MEDIA

WALLENSTEIN MEDIUM SLANT

Mar 30, 1988

Substantially Equivalent

HARDY MEDIA

POTATO DEXTROSE AGAR

Mar 07, 1988

Substantially Equivalent

HARDY MEDIA

BIOTIS (TM) SABHI (DOUBLE POUR)

Jan 28, 1988

Substantially Equivalent

OTISVILLE BIOPHARM, INC.

BIOTIS (TM) BCYE

Dec 04, 1987

Substantially Equivalent

OTISVILLE BIOPHARM, INC.

ECG BASED MEDIA

Nov 04, 1987

Substantially Equivalent

CENTRAL MEDIA

MIDDLEBROOK BASED MEDIA

Oct 28, 1987

Substantially Equivalent

CENTRAL MEDIA

MICRO CULTURE MEDIA P3141, P3136, P3148, P3748

Oct 23, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD

Sep 29, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300

Sep 29, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405

Aug 24, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002

Aug 24, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810

Aug 24, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

IAFP LOWENSTEIN JENSEN SLANT

Aug 11, 1987

Substantially Equivalent

I.A.F. PRODUCTION, INC.

IAFP T.S.A. W/5% SHEEP BLOOD

Aug 07, 1987

Substantially Equivalent

I.A.F. PRODUCTION, INC.

IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1

Aug 07, 1987

Substantially Equivalent

I.A.F. PRODUCTION, INC.

FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU

Jun 22, 1987

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

COOKED MEAT MEDIUM WITH IRON

Apr 14, 1987

Substantially Equivalent

HARDY MEDIA

TETRATHIONATE BROTH

Apr 14, 1987

Substantially Equivalent

HARDY MEDIA

MIDDLEBROOK 7H10 AGAR

Apr 14, 1987

Substantially Equivalent

HARDY MEDIA

HORSE BLOOD AGAR, ENRICHED

Apr 03, 1987

Substantially Equivalent

BIO MERIEUX, INC.

CHOCOLATE AGAR

Mar 31, 1987

Substantially Equivalent

MDS LABORATORIES, INC.

LOMBARD DOWELL AGAR BASE

Oct 29, 1986

Substantially Equivalent

GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.

VACUTAINER BRAND AGAR SLANT

Aug 04, 1986

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

BIOTIS BORDET GENGOU AGAR

Jul 03, 1986

Substantially Equivalent

OTISVILLE BIOTECH, INC.

BIOTIS COOKED MEAT

Feb 24, 1986

Substantially Equivalent

OTISVILLE BIOTECH, INC.

TRYPTIC SOY BLOOD AGAR

Nov 18, 1985

Substantially Equivalent

R. KENT RICHARDS, INC.

COLUMBIA 5% BLOOD AGAR

Oct 31, 1985

Substantially Equivalent

R. KENT RICHARDS, INC.

BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR

Oct 23, 1985

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

APL TSA WITH 5% SHEEP BLOOD

Aug 19, 1985

Substantially Equivalent

APL MEDICAL SUPPLIES

APL CHOCOLATE AGAR

Aug 19, 1985

Substantially Equivalent

APL MEDICAL SUPPLIES

TRYPTIC SOY AGAR W/5% SHEEP BLOOD

May 08, 1985

Substantially Equivalent

PREFERRED MICRO-MEDIA

CHOCOLATE AGAR

Apr 30, 1985

Substantially Equivalent

PREFERRED MICRO-MEDIA

CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL

Mar 25, 1985

Substantially Equivalent

RAPID CITY REGIONAL HOSPITAL, INC.

ENRICHED CULTURE MEDIUM

Mar 16, 1985

Substantially Equivalent

ROSEVILLE MEDICAL LABORATORIESU

BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG

Aug 20, 1984

Substantially Equivalent

OTISVILLE BIOTECH, INC.

SHEEP BLOOD AGAR

May 31, 1984

Substantially Equivalent

THE MONTANA DEACONESS MEDICAL CENTER

CHOCOLATE AGAR

May 31, 1984

Substantially Equivalent

MICROLINE SCIENTIFIC

CHOCOLATE AGAR

May 31, 1984

Substantially Equivalent

THE MONTANA DEACONESS MEDICAL CENTER

ENRICHED CULTURE MED. TRYPTIC SOY AGAR

May 21, 1984

Substantially Equivalent

MICROLINE SCIENTIFIC

ENRICHED CULTURE MED. FLUID THIOGLYC0

May 21, 1984

Substantially Equivalent

MICROLINE SCIENTIFIC

SELENITE CYSTINE BROTH

Oct 04, 1983

Substantially Equivalent

OTISVILLE BIOTECH, INC.

FILDES ENRICHMENT SOLUTON

Mar 08, 1983

Substantially Equivalent

GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.

BLOOD AGAR(TSA W/5% SHEEP BLOOD)

Feb 09, 1983

Substantially Equivalent

BIO MERIEUX, INC.

CHOCOLATE AGAR, ENRICHED

Feb 09, 1983

Substantially Equivalent

BIO MERIEUX, INC.

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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