510(k) Report

510(k) · Cleared

Cleared

Stage IV, CM-4000,Mattress Overlay System

K933091510(k) TraditionalCleared Dec 21, 1993180-day reviewClass II21 CFR 880.5550

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

Creative Medical, Inc. · FNM Mattress, Air Flotation, Alternating Pressure

Cleared on Dec 21, 1993 after a 180-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 21, 1993
Review
180 days
Class
Class II
Product code
FNM
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 K933091Source: 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 FNM? 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 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 FNM devices

FNM Mattress, Air Flotation, Alternating Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FNM

FDA has decided no FNM device since 2007.

Median 510(k) review, days · FNM

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

Recalls per year · FNM

1in 2025

2008: 42010: 12025: 1
2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FNM

128in 2025

2007: 332008: 352009: 332010: 562011: 2912012: 3032013: 2232014: 802015: 802016: 502017: 562018: 1152019: 1012020: 582021: 472022: 752023: 1972024: 2542025: 128
2007high 303 (2012) · low 33 (2007)2025

MAUDE reports naming product code FNM, 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—033
20080—435
20090—033
20100—156
20110—0291
20120—0303
20130—0223
20140—080
20150—080
20160—050
20170—056
20180—0115
20190—0101
20200—058
20210—047
20220—075
20230—0197
20240—0254
20250—1128
20260—0—

More from Creative Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K852654Cardiac Communicator 2000Creative Medical, Inc. · 1985

Recent decisions in FNM

The FNM category page

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  • K974319Mighty AirWheelchairs of Kansas · 1998
  • K972022ZAK-2000Cardio Systems, Inc. · 1998
  • K974070Physio/1000Physio Designs, Inc. · 1998
  • K972549SimpulseKinetic Concepts, Inc. · 1997

https://510kreport.com/device/K933091 · printed Nov 4, 2026

Cite this page

510(k) Report. “K933091: Stage IV, CM-4000,Mattress Overlay System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933091

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