K830497 is the FDA 510(k) clearance record for PEM-T, a class I device, cleared for Hedeco on 1983-04-05 under FDA product code JWZ (Kit, Screening, Trichomonas). FDA records list 4 510(k) clearances for Hedeco, from 1981-09-14 to 1983-04-05 . As of 2026-09-10 , FDA records show no recalls naming K830497.
Clearance record Decision date 1983-04-05 Received 1983-02-16 (48 days to decision) Product code JWZ Kit, Screening, TrichomonasRegulation 21 CFR 866.2660 Device class Class I Review panel Microbiology Applicant Hedeco 4221 Richmond Rd., NW, Walker MI Third party review No
Clearances, product code JWZ Trailing 12 months FDA records hold no clearances under product code JWZ in the trailing twelve months.
FDA records show no clearances under product code JWZ in the twelve months to October 2026. Show the numbers FIRST ARTICLE / WEEKLY
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About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
