510(k) Report

510(k) · Cleared

Cleared

Econo-Float Wheelchair Flotation Cushion

K802603510(k) TraditionalCleared Nov 12, 198022-day reviewClass I21 CFR 890.3910

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

Jefferson Industries, Inc. · KID Restraint, Wheelchair, Non-Protective

Cleared on Nov 12, 1980 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 12, 1980
Review
22 days
Class
Class I
Product code
KID
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K802603Source: 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.

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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 KID devices

KID Restraint, Wheelchair, Non-Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KID

FDA has decided no KID device since 2007.

Median 510(k) review, days · KID

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

Recalls per year · KID

No recall names KID since 2007.

Adverse event reports per year · KID

1in 2019

2009: 12019: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code KID, 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—00
20080—00
20090—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K802603: Econo-Float Wheelchair Flotation Cushion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802603

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