DeviceClearance

CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET— 510(k) K040636

Substantially Equivalent

Smiths Medical MD, Inc.

FDA 510(k) clearance K040636 for CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET, Substantially Equivalent on 2004-05-19. Applicant: Smiths Medical MD, Inc.. Device class: 2.

Clearance details

Applicant
Smiths Medical MD, Inc.
Product code
Code FPA
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FPA

view all

More clearances from Smiths Medical MD, Inc.

view all

Adverse events under product code FPA

product code FPA
Death
95
Injury
14,421
Malfunction
125,815
Other
30
Total
140,361

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

Recalls naming K040636

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040636.

Data sourced from openFDA. This site is unofficial and independent of the FDA.