510(k) Report

510(k) · Cleared

Cleared

Impulse 3000 Defibrillator Analyzer

K934254510(k) TraditionalCleared Nov 23, 199384-day reviewClass II21 CFR 870.5325

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

Dynatech/Nevada, Inc. · DRL Tester, Defibrillator

Cleared on Nov 23, 1993 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 23, 1993
Review
84 days
Class
Class II
Product code
DRL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K934254Source: 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 DRL? 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 DRL devices

DRL Tester, Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRL

1in 2019

2007: 12008: 22011: 12015: 12018: 12019: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRL

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

Recalls per year · DRL

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · DRL

2in 2013

2009: 12013: 2
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code DRL, 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
20071—00
20082—00
20090—01
20100—00
20111—00
20120—00
20130—02
20140—00
20151—10
20160—00
20170—00
20181—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Dynatech/Nevada, Inc.

6 FDA decisions under this applicant name. See the company

  • K942546Cufflink Non-Invasive Blood Pressure AnalyzerDynatech/Nevada, Inc. · 1995
  • K935817Medsim 300 Patient SimulatorDynatech/Nevada, Inc. · 1994
  • K897074Model 215M Patient SimulatorDynatech/Nevada, Inc. · 1990
  • K897029Model ECG100 SimulatorDynatech/Nevada, Inc. · 1990
  • K897096Model 404A I.V. Infusion Pump AnalyzerDynatech/Nevada, Inc. · 1990

Recent decisions in DRL

The DRL category page

  • K190437Delta 3300Netech Corporation · 2019
  • K182905UniPulseSeaward Group · 2018
  • K153210Defibrillator Analyzer Variable LoadBc Group International, Inc. · 2015
  • K110192Defibrillator Analyzer - DA-2006PBc Group International, Inc. · 20111 recall
  • K083347Impulse 7010 Defibrillator Selectable LoadsFluke Biomedical · 2008

https://510kreport.com/device/K934254 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934254: Impulse 3000 Defibrillator Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934254

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