1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT— 510(k) K895202

Name: FDA 510(k) clearance K895202
Creator: U.S. Food and Drug Administration
Published: 1989-09-15

Substantially Equivalent

Transidyne General Corp.

FDA 510(k) clearance K895202 for 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT, Substantially Equivalent on 1989-09-15. Applicant: Transidyne General Corp.. Device class: 2.

Clearance details

Applicant: Transidyne General Corp.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1989-08-18
Decision date: 1989-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.