510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,669
176,466 records, page 2628 of 3530
510(k) clearances, page 2628 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K893331Latex Examination GlovesP.T. Kencana Ronasakti PrimaLYYClass I
K893309Latex Examination GlovesP.T. Delta Waru Rubber IndustryLYYClass I
K893284Latex Examination GlovesAliga Export Sdn BhdLYYClass I
K893261Vinyl Examination GlovesClear Window Industrial, Ltd.LYZClass I
K893241Latex Exam GlovesSemodal Jaya Sdn. Bhd.LYYClass I
K893240Bion Ebv-M (Vca) Test SystemBion Ent., Ltd.LJNClass I
K893232Model V420 Direct Pressure Monitor & 427 WaveformCamino Laboratories, Inc.DSKClass II
K893184Latex Examination GlovesGreen Cross Medical Supplies Corp.LYYClass I
K893180Sensifit(r) Latex Examination GlovesInter-Asia Co., Inc.LYYClass I
K893178Latex Examination GlovesIntl. Marketing Assoc. Corp.LYYClass I
K893176Latex Examination GlovesMakintech Corp.LYYClass I
K893133Horizon 2110/Horizon 2210 264-Xxx-Xxx/261-Xxx-XxxMennen Medical, Inc.KLKClass II
K893102Vinyl Examination GlovesSamson Taiwan Corp.LYYClass I
K893101Latex Examination GlovesLi da Latex FactoryLYYClass I
K893090Patient Examination Gloves (Latex)Thai Chong Chemical Industrial Co., Ltd.LYYClass I
K893077Patient Examination Gloves (Latex)Britannia Group, Ltd.LYYClass I
K893045A-Dec Priority 1005 ChairA-dec, Inc.KLCClass I
K893044A-Dec Dental LightA-dec, Inc.EAZClass I
K893034Vhs 820 Humidifier, ModificationBear Medical Systems, Inc.BTTClass II
K893003Tocolytic Site Care Sup Kit #1001/100A/carry CaseUnited Medical Systems, Inc.FOZClass II
K892993Non-Sterile Latex Examination GlovesZeisin Industrial Co., Ltd.LYYClass I
K892986Patient Examination GloveLarkspur Consulting Co.LYYClass I
K892958Tacctile Patient Examination GlovesTrans American Chemical Corp.LYYClass I
K892935Resound Impression MaterialResound Corp.ELWClass II
K892916Patient Examination Gloves (Latex)China National Medicines & Health Prod. I/E Corp.LYYClass I
K892868Kaltostat Wound PackingCalgon Vestal Div.FROUnclassified
K892846Echo-Tip Disposable Amniocentesis NeedleCook Ob/GynHIOClass I
K892806Tuf-CoatG-C Intl. Corp.ELLClass II
K892804Newchill(tm) Cardiac InsulatorAcacia Laboratories, Inc.DWSClass I
K892790Patient Examination Gloves (Latex)Dann Overseas, Inc.LYYClass I
K892789Patient Examination Gloves (Latex)P.T. Indo Rama SyntheticsLYYClass I
K892766Patient Examination Gloves (Vinyl)Gigantic International Corp.LYZClass I
K892751Patient Examination Gloves (Dental)Baxter Healthcare CorporationLYYClass I
K892750Patient Examination Gloves (Latex)Baxter Healthcare CorporationLYYClass I
K892749Patient Examination Gloves (Latex)Industri Leva Sdn. Bhd.LYYClass I
K892746Patient Examination Gloves (Latex)Central Chemical Co., Ltd.LYYClass I
K892703Patient Examination Gloves (Latex)Shanghai-Foxboro Co., Ltd.LYYClass I
K892680Patient Examination Gloves (Natural Rubber)Texla Industries Sdn. Bhd.LYYClass I
K892611Patient Examination Gloves (Latex)Yty Industry (Manjung) Sdn. Bhd.LYYClass I
K892589Patient Examination Gloves (Latex)Patiria Sdn.Bhd.LYYClass I
K892588Patient Examination Gloves (Latex)Dynamic Plantations Sdn BhdLYYClass I
K892587Patient Examination Gloves (Vinyl)Wilson Glove Products Co., Ltd.LYZClass I
K892580Caretouch Examination GlovesJames River Corp.LYYClass I
K892579Anatomical Examination GlovesAnsell Pacific, Inc.LYYClass I
K892578Uht Patient Examination Gloves (Latex)United Health Technology, Inc.LYYClass I
K892573Latex Patient Examination GlovesEncore Products, Inc.LYYClass I
K892572Patient Examination Gloves (Latex)Jen I Hardware Co., Ltd.LYYClass I
K892570Patient Examination Gloves (Latex)Ansell Pacific, Inc.LYYClass I
K892559Patient Examination Gloves (Latex)Ya King Inc. Co., Ltd.LYYClass I
K892555Patient Examination Gloves (Latex)Thai Medical Latex Glove Co., Ltd.LYYClass I