NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1— 510(k) K121007

Clearance details

Applicant

Delta Med Srl

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2012-04-03

Decision date

2012-12-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Westmont, IL, US

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

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 →

• Z-2299-2021 — NEO DELTA Self Safe, I.V. Catheter REF 3738222Class II·Ongoing·Delta Med SpA·20210621
• Z-2300-2021 — NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 unitsClass II·Ongoing·Delta Med SpA·20210621
• Z-2301-2021 — NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522Class II·Ongoing·Delta Med SpA·20210621
• Z-2302-2021 — NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122Class II·Ongoing·Delta Med SpA·20210621
• Z-2303-2021 — NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822Class II·Ongoing·Delta Med SpA·20210621
• Z-2304-2021 — NEO DELTA SELFSAFE PUR T, I.V. Catheter:Class II·Ongoing·Delta Med SpA·20210621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121007.