510(k) Report

510(k) · Cleared

Cleared

Mmi/Gaeltec Catheter Tip Press. Transdu

K801757510(k) TraditionalCleared Aug 27, 198030-day reviewClass II21 CFR 876.1725

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

Medical Measurements, Inc. · FES Recorder, External, Pressure, Amplifier & Transducer

Cleared on Aug 27, 1980 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 27, 1980
Review
30 days
Class
Class II
Product code
FES
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801757Source: 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 FES? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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 FES devices

FES Recorder, External, Pressure, Amplifier & Transducer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FES

FDA has decided no FES device since 2007.

Median 510(k) review, days · FES

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

Recalls per year · FES

No recall names FES since 2007.

Adverse event reports per year · FES

No MAUDE report names FES since 2007.

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—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 Medical Measurements, Inc.

8 FDA decisions under this applicant name. See the company

  • K921062Gaeltec MPR SeriesMedical Measurements, Inc. · 1992
  • K902097Model TR Rectal Suction Biopsy TubeMedical Measurements, Inc. · 1990
  • K863479Modified Ict/B Intracranial Press. Trans. EpiduralMedical Measurements, Inc. · 1986
  • K801756Mmi/Gaeltec Catheter Tip TransducMedical Measurements, Inc. · 1980
  • K801880Mmi/Gaeltec Series 8T Diff. Press. TransMedical Measurements, Inc. · 1980

Recent decisions in FES

The FES category page

  • K890284Urodec 500Ferguson Medical · 1989

https://510kreport.com/device/K801757 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801757: Mmi/Gaeltec Catheter Tip Press. Transdu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801757

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