510(k) Report

510(k) · Cleared

Cleared

Zero-G (TM) Gel/Foam Mattress Topper

K911843510(k) TraditionalCleared May 30, 199135-day reviewClass I21 CFR 890.3175

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

Steridyne Corp. · KIC Cushion, Flotation

Cleared on May 30, 1991 after a 35-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 30, 1991
Review
35 days
Class
Class I
Product code
KIC
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K911843Source: 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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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 KIC devices

KIC Cushion, Flotation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KIC

FDA has decided no KIC device since 2007.

Median 510(k) review, days · KIC

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

Recalls per year · KIC

No recall names KIC since 2007.

Adverse event reports per year · KIC

8in 2025

2008: 12009: 12010: 22011: 102012: 182013: 72014: 132015: 312016: 22017: 52018: 72019: 82020: 42021: 122022: 62023: 122024: 142025: 8
2007high 31 (2015) · low 0 (2007)2025

MAUDE reports naming product code KIC, 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—01
20090—01
20100—02
20110—010
20120—018
20130—07
20140—013
20150—031
20160—02
20170—05
20180—07
20190—08
20200—04
20210—012
20220—06
20230—012
20240—014
20250—08
20260—0—

More from Steridyne Corp.

6 FDA decisions under this applicant name. See the company

  • K925352Clean Cuff Blood Pressure Cuff LinerSteridyne Corp. · 1993
  • K911269Mercury and Glass Fever ThermometerSteridyne Corp. · 1991
  • K842120ZERO-GSteridyne Corp. · 1984
  • K821314Fever MeterSteridyne Corp. · 1982
  • K801458Winter Head DressingSteridyne Corp. · 1980

Recent decisions in KIC

The KIC category page

  • K960189Gel-T CushionSpan-America Medical Systems, Inc. · 1996
  • K953352Proteam CushionIskra.Med · 1995
  • K954117Customcare Seating SystemSpan-America Medical Systems, Inc. · 1995
  • K950085Multicure (R) S Gel PadMultigestion (Deutschland) GmbH · 1995
  • K945667Micos Micropulse (TM) Alternating Pressure Wheelchair CushionMicos Medical Systems · 1995

https://510kreport.com/device/K911843 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911843: Zero-G (TM) Gel/Foam Mattress Topper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911843

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