Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MNW — Predicate Candidate Screening

79 FDA 510(k) clearances under this product code; the 50 most recent screened below.

141 daysmedian FDA review time
347 days90th percentile
79clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.2024-06-154220
K140045BODY COMPOSITION ANALYZERJawon Medical Co., Ltd.2015-02-184060
K141483BIOSPACE BODY COMPOSITION ANALYZERBiospace Corporation Limited2014-09-231100
K133872ARIA WIFI SMART SCALEFitbit, Inc.2014-06-021640
K140594BODY FAT ANALYZER AND SCALEConmo Electronic Company Limited2014-05-30840
K130777INBODYBiospace Corporation Limited2013-11-252490
K130856BIA / VITALITY ANALYZERIpgdx, LLC2013-11-252420
K130952PRECISION ONE LIFECARE; DETECTO; DETECTOPrecision One Lifecare, Ltd.2013-09-261740
K131394TRANSTEK GLASS BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.2013-09-181260
K130311TRANSTEK BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.2013-05-301110
K122388SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SESeca GmbH & Co. KG2013-05-022690
K123228INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)Biospace Corporation Limited2013-03-081440
K123781TRANSTEK GLASS BODY FAT ANALYZERZhongshan Transtek Electronics Co., Ltd.2013-01-09300
K122976BODY FAT SCALE MODEL SF-371Shenzhen Belter Health Measurement and Analysis TE2013-01-041000
K121971WITHINGS, SMART BODY SCALEZhongshan Transtek Electronics Co., Ltd.2012-09-27840
K120896WI-FI BODY SCALEAndon Health Co, Ltd.2012-07-261220
K121527WI-FI BODY SCALEShenzhen Healthcare Electronic Technology Co., Ltd.2012-06-28360
K112149WEIGHT AND BODY FAT SCALE SHINE BS0105Shine Overseas Marketing Limited2012-04-092580
K112951BODY ANALYSIS SCALEShenzhen Healthcare Electronic Technology Co., Ltd.2011-11-01280
K112932TRANSTEKZhongshan Transtek Electronics Co., Ltd.2011-11-01290
K111404HUIBAO BODY FAT SCALEZhongshan Huibao Weighing Apparatus Co., Ltd.2011-10-071410
K110689INBODYBiospace Corporation Limited2011-08-191570
K110928BODY ANALYSIS SCALE, MODEL BG 17Shenzhen Healthcare Electronic Technology Co., Ltd.2011-07-151020
K102191TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; Zhongshan Transtek Electronics Co., Ltd.2011-05-022720
K100183MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZERTanita Corp.2011-04-154490
K103026ELECTRO SENSOR -BODY COMPOSITIONLd Technology, LLC2011-03-291680
K082254MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORINGBodystat , Ltd.2011-02-079130
K082255QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTBodystat , Ltd.2011-02-079130
K101807STAYHEALTHY BODY COMPOSITION MONITOR-BCMStayhealthy, Inc.2011-01-262120
K092786INBODY, MODELS: 270, R20, R20BBiospace Corporation Limited2010-03-101810
K091369ELECTROFLUIDGRAPHAkern USA, LLC2009-10-141590
K092431BODY COMPOSITION ANALYZER, MODEL: IOI 353Jawon Medical Co., Ltd.2009-10-08620
K090479TANITA BODY COMPOSITION ANALYZER, MODEL SC-331Tanita Corporation of America2009-07-071330
K083838SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIESFook Tin Technologies Limited2009-05-121400
K082253BODYSTAT 1500 BODY COMPOSITION MONITORING UNITBodystat , Ltd.2008-11-251090
K081587KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530Krell Precision (Yang Zhou) Co., Ltd.2008-10-241410
K073334OHMNISCAN NGChristine Valmy, Inc.2008-08-222680
K073227SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300Aiia Communication, Inc.2008-03-201260
K072325BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205Jawon Medical Co., Ltd.2007-11-301020
K071884BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 Jawon Medical Co., Ltd.2007-08-09310
K070999BC (BODY COMPOSITION SOFTWARE)Rjl Systems, Inc.2007-08-021150
K062603BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230Biospace Corporation Limited2007-02-151670
K062652INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODYTanita Corporation of America2006-12-281120
K062043BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500Omron Healthcare, Inc.2006-11-071110
K060538BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 89Beaverite International Limited2006-10-102240
K053556BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5Jawon Medical Co., Ltd.2006-08-312540
K060642DUTECK BODY COMPOSITION ANALYZERDuteck Industrial Co., Ltd.2006-06-07890
K060552BC100 BODY COMPOSITION ANALYSIS SYSTEMAthletic Iq, Inc.2006-05-24830
K052319IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7Impedimed Pty , Ltd.2006-04-042220
K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERBiodynamics Corp.2006-03-162660

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda