PUMPETTE(TM)— 510(k) K884111

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K884111 for PUMPETTE(TM), Substantially Equivalent on 1988-12-14. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1988-09-29
Decision date: 1988-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.