Product Code: KPY FDA class 1 21 CFR 892.6500

Shield, Protective, Personnel

Radiology

This device is a protective personnel shield, such as a lead apron or barrier, used by healthcare workers to reduce occupational radiation exposure during diagnostic or therapeutic radiological procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KPY, regulated under 21 CFR 892.6500 within the Radiology specialty. No special flags apply.

View on FDA

510(k)s

FEI Numbers

194

Registration Numbers

194

Unique Applicants

Years Active

Basic Information

Product Code: KPY
Device Class: FDA class 1
Regulation Number: 892.6500
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K110900	DISPOSABLE THYROID COLLAR	Jun 24, 2011	Substantially Equivalent	Bloxr Corporation
K962622	INTRA-ORAL THERMOPLASTIC SHIELD	Oct 01, 1996	Substantially Equivalent	Medtec, Inc.
K954456	THERMOPLASTIC SHIELD	Dec 21, 1995	Substantially Equivalent	Medtec, Inc.
K954146	UTK-DTE AUTILARY SHIELD	Dec 06, 1995	Substantially Equivalent	Mallinckrodt Medical
K953610	AUKULYTE	Sep 26, 1995	Substantially Equivalent	Aukland Medical Plastics, Inc.
K951004	2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)	Apr 10, 1995	Substantially Equivalent	Kenex , Ltd.
K951003	KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)	Apr 03, 1995	Substantially Equivalent	Kenex , Ltd.
K940539	STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM	Mar 16, 1994	Substantially Equivalent	Standard Imaging, Inc.
K934206	MAVIG ANGIO SHIELD MODELS 6290 & 6272	Oct 07, 1993	Substantially Equivalent	F. Walter Hanel GmbH
K912378	DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS	Mar 18, 1992	Substantially Equivalent	Davis Lead Aprons, Inc.
K912327	DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.	Mar 18, 1992	Substantially Equivalent	Davis Lead Aprons, Inc.
K912326	DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS	Mar 18, 1992	Substantially Equivalent	Davis Lead Aprons, Inc.
K900970	RADIATION PROTECTION GLASSES	May 01, 1990	Substantially Equivalent	Infab Corp.
K896511	DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL	Dec 22, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K896289	RADIATION PROTECTION APRON	Dec 14, 1989	Substantially Equivalent	Infab Corp.
K871502	PERSONNEL PROTECTIVE SHIELD	May 08, 1987	Substantially Equivalent	Cis-Us, Inc.
K844160	VENTIBOX	Dec 17, 1984	Substantially Equivalent	Syncor Intl. Corp.
K811677	KRYPTON CART	Jul 02, 1981	Substantially Equivalent	Medi-Physics Inc. Dba Nycomed Amersham Imaging
K811068	BYPASS COIL	May 27, 1981	Substantially Equivalent	G.D. Searle and Co.
K810095	MOTI APRON	Feb 12, 1981	Substantially Equivalent	Moti Enterprises, Inc.
K802377	MOTI PROTECTIVE X-RAY MASK	Oct 31, 1980	Substantially Equivalent	Moti Enterprises, Inc.
K791522	FLOW MEDICAL X-RAY PROTECTIVE GLOVES	Oct 26, 1979	Substantially Equivalent	Flow X-Ray Corp.
K790639	GONAD SHIELD	Apr 23, 1979	Substantially Equivalent	The Mochlett Laboratories, Inc.
K790080	APRON, LEADED VINYL	Jan 26, 1979	Substantially Equivalent	Pinnacle Distributors, Inc.
K781852	GLOVE, SUPERFLEX MOLDED	Nov 15, 1978	Substantially Equivalent	Pinnacle Distributors, Inc.