TIMLEINE(TM) VENIPUNCTURE SYSTEM— 510(k) K870770

Name: FDA 510(k) clearance K870770
Creator: U.S. Food and Drug Administration
Published: 1987-04-23

Substantially Equivalent

Ipax, Inc.

FDA 510(k) clearance K870770 for TIMLEINE(TM) VENIPUNCTURE SYSTEM, Substantially Equivalent on 1987-04-23. Applicant: Ipax, Inc.. Device class: 1.

Clearance details

Applicant: Ipax, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1987-02-26
Decision date: 1987-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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 →

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