510(k) Report

Devices descending from K022278

5 later devices reach TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042426TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series…Taiject Medical Device Co., Ltd.20040—
+1K040105Yue Pfong Safety Syringe (3ML)Yue Pfong International Industrial Co., Ltd.20040—
+1K031909Betec Retractable Safety Syringe (5ML)Betec Medical Science Co., Ltd.20030—
+1K031062TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin)Taiject Medical Device Co., Ltd.20031—
+1K023458TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Taiject Medical Device Co., Ltd.20022—