BABYLANCE HEEL INCISION DEVICE— 510(k) K130132

Clearance details

Applicant

Medipurpose Pte. , Ltd.

Product code

Code FMK

Device class

Class 2

Regulation

21 CFR 878.4850

Advisory panel

General, Plastic Surgery

Date received

2013-01-18

Decision date

2013-02-11

Decision

Substantially Equivalent

Clearance type

Special

Location

Alpharetta, GA, US

• K262526 — Safety lancet (XL)2026-09-13
• K261045 — Verifine Safety Lancets2026-05-01
• K260191 — Safety lancet (XXXVII)2026-03-31
• K253605 — Safety Heel Lancet2026-02-20
• K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)2026-02-12

• K222224 — SurgiLance® Safety Lancet2022-09-22
• K110062 — MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG2011-09-01
• K101145 — SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB2502010-10-21
• K101417 — BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN2002010-10-19

Injury

133

Malfunction

1,278

Other

1

Total

1,412

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →