ADD-A-VIAL— 510(k) K904855

Clearance details

Applicant

Kendall Mcgaw Laboratories, Inc.

Product code

Code LHI

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1990-10-29

Decision date

1990-11-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

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• K905610 — MICRORATE INTELLIGENT PUMP1991-03-01
• K905611 — MICRORATE PLUS INTELLIGENT PUMP1991-03-01
• K904518 — VOLUMETRIC INFUSION PUMP1990-10-17
• K903809 — PROTECTED NEEDLE WITH OR WITHOUT IV SET1990-10-03
• K901065 — INFUSION PUMP1990-08-21

Injury

207

Malfunction

7,820

Other

3

Total

8,030

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-0424-2014 — 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.Class II·Terminated·B. Braun Medical, Inc.·20130404
• Z-0425-2014 — 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.Class II·Terminated·B. Braun Medical, Inc.·20130404

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904855.