510(k) Report

510(k) · Cleared

Cleared

Head-UP Supine Safety Support Cushion

K821306510(k) TraditionalCleared Jun 7, 198234-day reviewClass I21 CFR 878.4950

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

Med-Life, Inc. · EPW Support, Head, Surgical, Ent

Cleared on Jun 7, 1982 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 7, 1982
Review
34 days
Class
Class I
Product code
EPW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K821306Source: 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 EPW devices

EPW Support, Head, Surgical, Ent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EPW

FDA has decided no EPW device since 2007.

Median 510(k) review, days · EPW

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

Recalls per year · EPW

No recall names EPW since 2007.

Adverse event reports per year · EPW

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code EPW, 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—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Med-Life, Inc.

3 FDA decisions under this applicant name. See the company

  • K844420Med-Life Emergency Oxygen Regreather/ResuscitatorMed-Life, Inc. · 1984
  • K821307AnesthecacheMed-Life, Inc. · 1982

Recent decisions in EPW

The EPW category page

  • K801326Anspach Operating Table Support/SpinalThe Anspach Effort, Inc. · 1980

https://510kreport.com/device/K821306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K821306: Head-UP Supine Safety Support Cushion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821306

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