Atlas FDA

FRW

48 FDA 510(k) clearances · Product code

67 daysmedian time to decision
274 days90th percentile
48clearances measured

FDA profile

Official device name
Scale, Patient
Device class
Class I (low risk)
Regulation
21 CFR 880.2720
Medical specialty
General Hospital
Adverse events (MAUDE)
2007: 3 · 2008: 2 · 2009: 4 · 2010: 4 · 2011: 5 · 2013: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OLYMPIC SMART SCALE MODEL 50/50RA (K955357)Olympic Medical Corp.1996-01-30
OLYMPIC SMART SCALE (K954846)Olympic Medical Corp.1995-12-14
OLYMPIC SMART SCALE (K955177)Olympic Medical Corp.1995-12-14
WARM-SCALE (K952649)Olympic Medical Corp.1995-08-15
ADVANCED IN-BED WEIGH SYSTEM (K943587)Future Systems, Inc.1994-09-22
DIGITAL BABY SCALE MODEL BLB-12 (K932572)Tanita Corp. of America1993-11-16
MODEL 9100 H.R. INFANT SCALE (K926174)Acme Medical Scale Co.1993-10-25
EZ PUMP (K926446)Alphamed, Inc.1993-09-27
3M MODEL 200RT RATE TAPER INFUSION PUMP (K926059)3M Health Care, Ltd.1993-08-16
3M MODEL 280RT RATE TAPER INFUSION PUMP (K926058)3M Health Care, Ltd.1993-08-16
SANITAS PATIENT SCALE (K930626)Dutton-Lainson Co.1993-08-06
DISETRONIC DOLOMAT PUMP (K920063)Disetronic Medical Systems1993-08-03
DETECTO MODEL 6700 SERIES (K924847)Cardinal Scale Mfg. Co.1993-05-24
MODEL 5002 LIFT WEIGH-SCALE (K922119)Acme Medical Scale Co.1993-02-03
FAIRBANKS BABY SCALE (K920812)Fairbanks Scales, Inc.1992-05-13
ARJO CENTURY SCALES WITH REMOTE (K920074)Arjo-Century, Inc.1992-04-06
SCALE-TRONIX PLATFORM SCALE (K912662)Scale-Tronix, Inc.1992-03-27
U.S. MEDICAL PS-2000 PEDIATRIC SCALE (K910582)U.S. Medical Corp.1991-03-21
U.S. MEDICAL PS-1000 PEDIATRIC SCALE (K910581)U.S. Medical Corp.1991-03-21
U.S. MEDICAL PS-3000 NEONATAL SCALE (K910583)U.S. Medical Corp.1991-03-21
SENTRY SCALE (K905122)Apollo Enterprise, Ltd. Co.1991-03-15
APOLLO MOBILE SCALE (K905061)Apollo Enterprise, Ltd. Co.1991-02-12
SMART SCALE X-RAY PLATFORM (K904138)Olympic Medical Corp.1990-11-19
SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED (K904286)Scale-Tronix, Inc.1990-10-01
SCALE-TRONIX INCUBATOR SCALE MODEL:4050 (K902260)Scale-Tronix, Inc.1990-08-14
VAAKA BABY SCALE (K902545)Ferguson Medical1990-07-26
OLYMPIC SMART SCALE PEDIATRICS MODEL 50 (K901522)Olympic Medical Corp.1990-06-22
SAFEWEIGH MAGIC SCALE (K872524)Health Care Innovations, Inc.1987-10-09
COMFORTWEIGH (K871771)Curlington Industrial Electronics, Inc.1987-06-24
OLYMPIC SMART SCALE (K871104)Olympic Medical Corp.1987-05-22
WARM WEIGH MODEL N-10 INFANT SCALE (K870888)Air-Shields, Inc.1987-03-17
MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP (K864327)Medtronic Minimed1987-02-06
WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE (K864953)Dittmar and Penn Corp.1987-01-21
HOYER DIGITAL ELECTRONIC SCALE (K862477)Ted Hoyer & Co., Inc.1986-09-03
GRAM-MA NEONATAL SC (K853475)Kentec Medical, Inc.1985-09-05
ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400 (K852278)Acme Medical Scale Co.1985-06-07
HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES (K852035)Continental Scale Corp.1985-05-29
ACME LOW-PROFILE CHAIR SCAL 7300 (K851014)Acme Medical Scale Co.1985-03-27
ACME DIGITAL INFANT SCALE-30 (K841534)Acme Medical Scale Co.1984-05-31
HAMILTON PEDIATRICS SCALE (K833754)Befour, Inc.1984-01-11
INFUSION PUMP ACCESS. #60-01-5 (K830317)Windsor Medical, Inc.1983-03-31
DIGITAL BEDSIDE SCALE #5000 (K830171)Acme Medical Scale Co.1983-02-18
SECA DIGITAL BABY SCALE 727 (K822135)Seca Corp.1982-07-30
SECA CHAIR SCALE-721 (K822043)Seca Corp.1982-07-28
SECA LIGHT WEIGHT BABY SCALE 744 (K822042)Seca Corp.1982-07-28
MODEL AS* 6C INFUSION PUMP (K791566)Baxter Healthcare Corp1979-11-13
SCALE, ACME DIGITAL BEDSIDE (K781832)Acme Medical Scale Co.1978-12-07
WEIGHING STATION, MOBILE PATIENT (K760545)Gaymar Industries, Inc.1976-11-12

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