510(k) Report

510(k) · Cleared

Cleared

Bedding Pads Eggcreate Pads

K802781510(k) TraditionalCleared Dec 10, 198035-day reviewClass I21 CFR 880.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Leemart Bedding Mfg. Co. · IKY Mattress, Flotation Therapy, Non-Powered

Cleared on Dec 10, 1980 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 10, 1980
Review
35 days
Class
Class I
Product code
IKY
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K802781Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IKY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All IKY devices

IKY Mattress, Flotation Therapy, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKY

FDA has decided no IKY device since 2007.

Median 510(k) review, days · IKY

Too few IKY 510(k)s in any year since 2007 to give a median.

Recalls per year · IKY

1in 2011

2009: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IKY

39in 2025

2007: 42008: 152009: 232010: 362011: 1192012: 472013: 1642014: 2072015: 742016: 622017: 272018: 1312019: 452020: 162021: 132022: 442023: 232024: 4332025: 39
2007high 433 (2024) · low 4 (2007)2025

MAUDE reports naming product code IKY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—04
20080—015
20090—123
20100—036
20110—1119
20120—047
20130—0164
20140—0207
20150—074
20160—062
20170—027
20180—0131
20190—045
20200—016
20210—013
20220—044
20230—023
20240—0433
20250—039
20260—0—

Recent decisions in IKY

The IKY category page

  • K914921SCM-3 and AccessoriesGaymar Industries, Inc. · 1992
  • K813226Gel Flotation MattressJefferson Industries, Inc. · 1981
  • K802833Tetra Natal-Mat Water Flotation Mat.Tetra Group U.S.A., Inc. · 1980
  • K780779Econo-Float Water Flotation MattressJefferson Industries, Inc. · 1978
  • K772062Neonatal Flotation SystemMedpro, Inc. · 1977

https://510kreport.com/device/K802781 · printed Nov 6, 2026

Cite this page

510(k) Report. “K802781: Bedding Pads Eggcreate Pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802781

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026