510(k) · Cleared
ClearedModels Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Tek Instruments, Inc. · DRL Tester, Defibrillator
Cleared on Nov 17, 1995 as substantially equivalent to K904159 (Bio-Tek Instruments, Inc., 1991) and 2 other predicates after a 59-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 17, 1995
- Review
- 59 days
- Class
- Class II
- Product code
- DRL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K904159 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904159 Defibrillator Analyzer Model Qed-5Bio-Tek Instruments, Inc. · 1991
- This deviceK954391 Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional…Bio-Tek Instruments, Inc. · 1995
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904159 | Defibrillator Analyzer Model Qed-5 | Bio-Tek Instruments, Inc. | 1991 | — |
| 0 (this device) | K954391 | Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal… | Bio-Tek Instruments, Inc. | 1995 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904159 | Defibrillator Analyzer Model Qed-5Summary page 1…~ to w I]er devices: The QED-6 incorporates features which are similar to those on .Similari~—-,,-, the Bio-T(J: Q“~ [)-5, Defibrillator Analyzer K904 159/& and the Bio-Tek PMA- 1, Pacemaker Analyzer K9031 66/~ which are two different types of devices 1t is also similar to the… | 1991 |
| * | K903966 | External Pacemaker Analyzer Model Pma-1 Our reading of the summary gave K903166, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bio-Tek PMA-1 Pacemaker Analyzer”. | 1991 |
| * | K941404 | Impulse 4000 Defibrillator/Transcutaneous Pacer AnalyzerSummary page 1…alyzer K9031 66/~ which are two different types of devices 1t is also similar to the Dynatech >(CV a impulse 4000 Defibrillator/ Transcutaneous Pacemaker Analyzer K941404. The technolc~g: .Ised is similar to the predicates. Tests Wer(: ~on(l,lcted by the Bio-Tek development Engineers i… | 1994 |
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.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All DRL devicesDRL Tester, Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRL
1in 2019
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRL
2in 2013
MAUDE reports naming product code DRL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The QED-6 comprises a series of defibrillator analyzers with pacemaker analysis features. The devices have identical hardware, which can be factory modified by software to configure various options. The devices are intended to be used to: A) Analyze the energy which is delivered by defibrillator, including Joules, peak current, peak voltage and overshoot. Output to a printer or oscilloscope in order to “playback” the defibrillator pulse waveform and…
Read the full statement (165 words)
The QED-6 comprises a series of defibrillator analyzers with pacemaker analysis features. The devices have identical hardware, which can be factory modified by software to configure various options. The devices are intended to be used to:
A) Analyze the energy which is delivered by defibrillator, including Joules, peak current, peak voltage and overshoot. Output to a printer or oscilloscope in order to “playback” the defibrillator pulse waveform and output the other information which the analyzer has recorded. These features are on all models, QED-6, QED-6M, and QED-6H.
B) Measure synchronization time (cardiovascular delay time) of synchronized defibrillators. All models QED-6, QED-6M and QED-6H.
C) Output a variety of performance and arrhythmia waveforms to the defibrillator paddles or ECG jacks for monitor verification. Models QED-6M and QED-6H.
D) Measure charge time of defibrillator. Models QED-6M and QED-6H.
E) Analyze the output signals of non-invasive pacemakers, such as the transthoracic types which are present on some defibrillators, such as the Physio Controls LifePak 8. On Model QED-6H.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K954391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954391: Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954391
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026