BEDDING PADS EGGCREATE PADS— 510(k) K802781

Name: FDA 510(k) clearance K802781
Creator: U.S. Food and Drug Administration
Published: 1980-12-10

Substantially Equivalent

Leemart Bedding Mfg. Co.

FDA 510(k) clearance K802781 for BEDDING PADS EGGCREATE PADS, Substantially Equivalent on 1980-12-10. Applicant: Leemart Bedding Mfg. Co.. Device class: 1.

Clearance details

Applicant: Leemart Bedding Mfg. Co.
Product code: Code IKY
Device class: Class 1
Regulation: 21 CFR 880.5150
Advisory panel: General Hospital
Date received: 1980-11-05
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IKY

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K914921 — SCM-3 AND ACCESSORIES1992-03-12
K813226 — GEL FLOTATION MATTRESS1981-12-02
K802833 — TETRA NATAL-MAT WATER FLOTATION MAT.1980-12-10
K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS1978-05-19
K772062 — NEONATAL FLOTATION SYSTEM1977-11-15

Adverse events under product code IKY

product code IKY

Death: 5
Malfunction: 491
Other: 4
Total: 500

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.