RADIATION STERILIZED ADMIN. SET— 510(k) K811078

Clearance details

Applicant

Travenol Laboratories, S.A.

Product code

Code FPA

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1981-04-20

Decision date

1981-07-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M13091987-10-13

Death

95

Injury

14,421

Malfunction

125,815

Other

30

Total

140,361

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-1268-2013 — A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.Class II·Terminated·Baxter Healthcare Corp.·20130328

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K811078.