510(k) Report

510(k) · Cleared

Cleared

Episensor Plus

K920740510(k) TraditionalCleared Mar 7, 1994747-day reviewClass II21 CFR 880.2460

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

Industrias Palex C/O Dma Med-Chem Corp. · CAR Monitor, Spinal-Fluid Pressure, Electrically Powered

Cleared on Mar 7, 1994 after a 747-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 7, 1994
Review
747 days
Class
Class II
Product code
CAR
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 K920740Source: 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 CAR devices

CAR Monitor, Spinal-Fluid Pressure, Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAR

FDA has decided no CAR device since 2007.

Median 510(k) review, days · CAR

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

Recalls per year · CAR

No recall names CAR since 2007.

Adverse event reports per year · CAR

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

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

More from Industrias Palex C/O Dma Med-Chem Corp.

5 FDA decisions under this applicant name. See the company

  • K920366Ulcuflex Hydrocoloid PowderIndustrias Palex C/O Dma Med-Chem Corp. · 1992
  • K920368Ulcuflex Hydrocolloid PasteIndustrias Palex C/O Dma Med-Chem Corp. · 1992
  • K920367Ulcuflex Hydroculloid DressingIndustrias Palex C/O Dma Med-Chem Corp. · 1992
  • K871628Palex (R) OstomyIndustrias Palex C/O Dma Med-Chem Corp. · 1987

Recent decisions in CAR

The CAR category page

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  • K915577Impraflo Postoperative Autotransfusion DeviceImpra, Inc. · 1992

https://510kreport.com/device/K920740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920740: Episensor Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920740

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