510(k) Report

510(k) · Cleared

Cleared

Paceview

K895535510(k) TraditionalCleared Mar 19, 1990187-day reviewClass II21 CFR 870.3640

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

Micromedical · KRE Analyzer, Pacemaker Generator Function, Indirect

Cleared on Mar 19, 1990 after a 187-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 19, 1990
Review
187 days
Class
Class II
Product code
KRE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K895535Source: 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 KRE? 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 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 KRE devices

KRE Analyzer, Pacemaker Generator Function, Indirect: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRE

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRE

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

Recalls per year · KRE

No recall names KRE since 2007.

Adverse event reports per year · KRE

2in 2023

2014: 22015: 12016: 72017: 12018: 62019: 32020: 42021: 142022: 22023: 2
2007high 14 (2021) · low 0 (2007)2025

MAUDE reports naming product code KRE, 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
20081—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—02
20150—01
20160—07
20170—01
20180—06
20190—03
20200—04
20210—014
20220—02
20230—02
20240—00
20250—00
20260—0—

More from Micromedical

2 FDA decisions under this applicant name. See the company

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The KRE category page

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  • K032926Ekg SpeaksMedtronic Vascular · 2003
  • K922742HPM 40 Heart Pacemaker MonitorBiotronik, GmbH & Co. · 1993
  • K915632Paceart CPTS-86/12Paceart, Inc. · 1992

https://510kreport.com/device/K895535 · printed Nov 4, 2026

Cite this page

510(k) Report. “K895535: Paceview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895535

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