Atlas FDA

KPY

25 FDA 510(k) clearances · Product code

47 daysmedian time to decision
294 days90th percentile
25clearances measured

FDA profile

Official device name
Shield, Protective, Personnel
Device class
Class I (low risk)
Regulation
21 CFR 892.6500
Medical specialty
Radiology
Adverse events (MAUDE)
2005: 2 · 2006: 2 · 2007: 4 · 2008: 3 · 2009: 3 · 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DISPOSABLE THYROID COLLAR (K110900)Bloxr Corporation2011-06-24
INTRA-ORAL THERMOPLASTIC SHIELD (K962622)Medtec, Inc.1996-10-01
THERMOPLASTIC SHIELD (K954456)Medtec, Inc.1995-12-21
UTK-DTE AUTILARY SHIELD (K954146)Mallinckrodt Medical1995-12-06
AUKULYTE (K953610)Aukland Medical Plastics, Inc.1995-09-26
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (K951004)Kenex , Ltd.1995-04-10
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (K951003)Kenex , Ltd.1995-04-03
STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (K940539)Standard Imaging, Inc.1994-03-16
MAVIG ANGIO SHIELD MODELS 6290 & 6272 (K934206)F. Walter Hanel GmbH1993-10-07
DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (K912326)Davis Lead Aprons, Inc.1992-03-18
DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. (K912327)Davis Lead Aprons, Inc.1992-03-18
DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS (K912378)Davis Lead Aprons, Inc.1992-03-18
RADIATION PROTECTION GLASSES (K900970)Infab Corp.1990-05-01
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL (K896511)E.I. Dupont DE Nemours & Co., Inc.1989-12-22
RADIATION PROTECTION APRON (K896289)Infab Corp.1989-12-14
PERSONNEL PROTECTIVE SHIELD (K871502)Cis-Us, Inc.1987-05-08
VENTIBOX (K844160)Syncor Intl. Corp.1984-12-17
KRYPTON CART (K811677)Medi-Physics Inc. Dba Nycomed Amersham Imaging1981-07-02
BYPASS COIL (K811068)G.D. Searle and Co.1981-05-27
MOTI APRON (K810095)Moti Enterprises, Inc.1981-02-12
MOTI PROTECTIVE X-RAY MASK (K802377)Moti Enterprises, Inc.1980-10-31
FLOW MEDICAL X-RAY PROTECTIVE GLOVES (K791522)Flow X-Ray Corp.1979-10-26
GONAD SHIELD (K790639)The Mochlett Laboratories, Inc.1979-04-23
APRON, LEADED VINYL (K790080)Pinnacle Distributors, Inc.1979-01-26
GLOVE, SUPERFLEX MOLDED (K781852)Pinnacle Distributors, Inc.1978-11-15

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