Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

DWL · Predicate Candidate Screening

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

80 daysmedian FDA review time
218 days90th percentile
64clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141127MEDLINE ANTI-EMBOLISM STOCKINGMedline Industries, Inc.2014-08-211120
K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)Bsn Medical, Inc.2013-07-10480
K122485ENCIRCLE COMPRESSION THERAPY STOCKINGEncircle Medical Devices , Ltd.2013-04-232520
K123820BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSBossong Hosiery Mills, Inc.2013-04-021110
K123085FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUT3M Company2012-12-20800
K123398DR. SCHOLL'S COMPRESSION SOCKSRenfro Corporation2012-12-18430
K123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESSBsn Medical, Inc.2012-12-18290
K121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TSurgical Appliance Industries, Inc.2012-04-27150
K112769CURAD COMPRESSION HOSIERYMedline Industries, Inc.2012-03-011600
K111662VENOTRAIN CURAFLOWBauerfeind AG2011-10-041120
K101614HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809Dm Systems, Incorporated2011-01-132180
K101224SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGSGriffiths and Nielsen, Ltd.2010-12-032140
K101906SHAPE TO FIT COMPRESSION WEARTsung Hau Technology Co., Ltd.2010-09-17710
K0928921-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-8I-Ming Sanitary Materials Co., Ltd.2010-08-033160
K090921ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-Beiersdorf, Inc.2009-12-182610
K091141THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMENKnit-Rite, Inc.2009-07-24950
K062873SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREE.C.I. USA Corporation2007-03-201760
K061411TORBOT VASCULAR COMPRESSION GARMENTSTorbut Group, Inc.2006-10-181490
K051324MEDI BUTLERMedi USA, LP2005-12-051990
K040353FLIGHT SOCKSsl Americas, Inc.2004-03-11280
K032325JOBST TRAVEL SOCKSBsn-Jobst, Inc.2003-08-28310
K022233HYDROBOOTIncappe, Inc.2002-08-12330
K020538BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSBoehringer Laboratories2002-05-15850
K021102DM SLEEVEEmily Iker M.D., A.P.C.2002-05-08340
K020592ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001Alba-Waldensian, Inc.2002-04-03400
K013852JOBST READY-TO-WEAR GAUNTLETBsn-Jobst, Inc.2002-01-28690
K001300D. R. MEDICAL CONTROLLED PRESSURE GARMENTSConfection Medicale D.R., Inc.2000-08-301280
K991570JOBST READY-TO-WEAR ARM SLEEVESBeiersdorf-Jobt, Inc.1999-08-201070
K981296GEEN MEDISOXGeen Healthcare, Inc.1998-05-29500
K964103OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGSTournier-Bottu S.A.1997-01-06870
K963573ELVAREXJobst A Beiersdorf Co.1996-10-16410
K960931CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKICarolina Narrow Fabric Co.1996-05-23770
K961177CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCCarolina Narrow Fabric Co.1996-04-15210
K955138ANTI-EM/GP STOCKINGSJobst Institute, Inc.1995-12-13300
K954295MARLENE STOCKINGS & TIGHTSProfessional Products, Inc.1995-11-08550
K951234MEDICAL SUPPORT STOCKINGSJobst A Beiersdorf Co.1995-05-18590
K943734MEDICAL SUPPORT STOCKINGS 2001/2002Julius Zorn, Inc.1994-10-19780
K941926MEDI STRUMPFMedi USA, LP1994-06-15560
K925154JOBST-CUSTOMJobst Institute, Inc.1994-04-045380
K925643RX FIT MEDICAL STOCKINGSElastic Therapy, Inc.1993-12-063920
K925417KENDALL HOME RX THERAPEUTIC STOCKINGKendall Healthcare Products Co. Div.Of Tyco Health1993-06-042200
K920444ULTIMATEJobst Institute, Inc.1992-04-20770
K905413JUZO-RESPIRA ANTI-EMBOLISM STOCKINGJulius Zorn, Inc.1991-05-171650
K905631COMPRINET, COMTESSE AND BELLAVAR STOCKINGSJobst Institute, Inc.1991-03-07800
K902497SCD THERAPEUTIC STOCKING SYSTEMKendall Healthcare Products Co. Div.Of Tyco Health1990-08-15710
K894071COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSESara Lee Corp.1989-10-181320
K892867ULCERCAREJobst Institute, Inc.1989-07-20920
K883186WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGSWright Linear Pump, Inc.1988-11-211160
K883633ULTRACAREJobst Institute, Inc.1988-10-18540
K873280ENHANCE SUPPORT HOSEKimberly-Clark Corp.1987-10-09530

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