Atlas FDA

FXP

36 FDA 510(k) clearances · Product code

36 daysmedian time to decision
295 days90th percentile
36clearances measured

FDA profile

Official device name
Cover, Shoe, Operating-Room
Device class
Class I (low risk)
Regulation
21 CFR 878.4040
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2004: 5 · 2005: 5 · 2006: 3 · 2007: 2 · 2008: 3 · 2025: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PRIMED SHOE COVERS, PRIMED HEAD COVERS (K971076)Primeline Medical Products, Inc.1998-01-13
FAR-EAST SHOE COVERS (K971191)Far East Science & Technology Development Co., Ltd.1997-07-10
CONVERTORS IMPERVIOUS SHOE COVERS (K970815)Allegiance Healthcare Corp.1997-03-27
SHOE COVER, NON-STERILE (K961342)Copioumed Intl., Inc.1996-12-30
FLUID BARRIER BOOT KNEE & ANKLE-HIGH (K955835)Instrument Makar, Inc.1996-11-19
NIOMED NON-SKID SHOE COVERS (K952937)Amerasia Corp.1995-10-23
NIOMED SHOE COVERS (K952897)Amerasia Corp.1995-10-23
OREX SHOE COVERS (K943034)Thantex Specialties, Inc.1995-01-02
KAPPLER PRO/VENT BOOT (K932738)Kappler, Inc.1994-03-29
REUSABLE LIQUIDPROOF BOOTIE (K925815)Amsco Sterile Recoveries, Inc.1993-07-09
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS (K914702)Depuy, Inc.1993-01-29
DISPOSABLE SHOE COVER (K913628)Gem Nonwovews, Inc.1991-10-04
DISPOSABLE SHOE COVER (K894383)American Threshold Industries, Inc.1989-09-12
TECNOL GAITERS PRODUCT NUMBER 47725-010 (K893702)Tecnol New Jersey Wound Care, Inc.1989-06-23
SKID RESISTANT, LONG LASTING SHOE COVERS (K883657)James River Corp.1988-09-15
COVER, SHOE OPERATING ROOM (K882280)A Plus International, Inc.1988-06-23
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 (K882128)Tecnol New Jersey Wound Care, Inc.1988-06-15
CARETEX SKID RESISTANT SHOE COVERS (K880093)James River Corp.1988-01-29
SHOE COVERS (K874064)Interpro Intl., Inc.1987-11-04
NON-SKID SHOE COVERS (K872797)Abco Dealers, Inc.1987-08-04
COVER, SHOE OPERATING ROOM (K865023)Ulti-Med Intl., Inc.1987-01-12
CARETEX SHOE COVERS (K864550)James River Corp.1986-12-24
NONCONDUCTIVE SHOE COVER (K864026)Kimberly-Clark Corp.1986-10-30
DISPOSABLE SHOE COVERS AND NURSES CAPS (K862726)Abco Dealers, Inc.1986-08-01
TECNOL PERSONAL SHOE COVER (K861528)Technol, Inc.1986-05-12
OVERSHOES (SURCHAUSSURES (K851554)Roseburg SA1985-04-30
SHOE COVERS (K844705)Medicon, Inc.1985-01-10
PHARMA-PLAST SINGLE USE OVERSHOES (K843475)Zimmar Consulting , Ltd.1984-10-31
MICRO-MITT (K830821)CooperVision, Inc.1983-04-27
CONDUCTIVE SHOE COVERS (K801617)Procter & Gamble Mfg. Co.1980-08-04
NON-CONDUCTIVE SHOE COVERS (K801616)Procter & Gamble Mfg. Co.1980-08-04
FLARE DIS. CONDUCTIVE&NON. SHOE COVERS (K800809)Flare Products, Inc.1980-05-20
SHIELD PERFECT FIT; DURA-FIT, DISPOS. (K800528)American Convertors Div., American Pharmaseal1980-04-16
SHOE COVERS (K780590)Abco Dealers, Inc.1978-05-09
P.S.M. JUSTA COVER (K761072)The Owenby Co.1976-12-02
BARNER SHOE COVERS & COVERBOOTS (K760779)Surgikos, Inc.1976-11-02

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