510(k) Report

510(k) · Cleared

Cleared

Orex Medical Bedding

K944953510(k) TraditionalCleared Dec 2, 199456-day reviewClass I21 CFR 880.6060

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

Thantex Specialties, Inc. · KME Bedding, Disposable, Medical

Cleared on Dec 2, 1994 after a 56-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 2, 1994
Review
56 days
Class
Class I
Product code
KME
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 K944953Source: 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 KME? 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 KME devices

KME Bedding, Disposable, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KME

FDA has decided no KME device since 2007.

Median 510(k) review, days · KME

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

Recalls per year · KME

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

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

Adverse event reports per year · KME

3in 2025

2008: 32009: 52010: 32011: 52012: 22013: 22015: 22016: 22017: 62019: 72020: 52021: 22022: 12023: 22024: 22025: 3
2007high 7 (2019) · low 0 (2007)2025

MAUDE reports naming product code KME, 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—03
20090—05
20100—03
20110—05
20120—02
20130—02
20140—00
20150—02
20160—02
20170—16
20180—00
20190—07
20200—05
20210—02
20220—01
20230—02
20240—02
20250—03
20260—0—

More from Thantex Specialties, Inc.

21 FDA decisions under this applicant name. See the company

  • K970547Isolyser SDS Sharps ContainerThantex Specialties, Inc. · 1997
  • K961083Orex Surgeon's VestThantex Specialties, Inc. · 1996
  • K942200Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsThantex Specialties, Inc. · 1995
  • K943626Isolyser Sharps Management System SMSThantex Specialties, Inc. · 1995
  • K945755Orex (R) O.R Equipment DrapesThantex Specialties, Inc. · 1995

Recent decisions in KME

The KME category page

  • K042145Ready-Heat BlanketTechtrade, LLC · 2004
  • K933636Dispose-a-SheetBelmac Healthcare Corp. · 1994
  • K932539Doctor Down --Rescue WrapThree Dog Down · 1993
  • K922143American Burn SheetAmerican Silk Sutures, Inc. · 1992
  • K915303Foil Baby BuntingGam Industries, Inc. · 1992

https://510kreport.com/device/K944953 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944953: Orex Medical Bedding.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944953

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