510(k) Report

510(k) · Cleared

Cleared

Zipprep Electrode

K940802510(k) TraditionalCleared Jun 22, 1994120-day reviewClass II21 CFR 870.2360

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

Aspect Medical Systems, Inc. · DRX Electrode, Electrocardiograph

Cleared on Jun 22, 1994 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Jun 22, 1994
Review
120 days
Class
Class II
Product code
DRX
Recalls
None
Predicates
0

16 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared1996: 1 descendant cleared2005: 3 descendants cleared2009: 1 descendant cleared2000: 1 descendant cleared2002: 1 descendant cleared2003: 1 descendant cleared2008: 2 descendants cleared2023: 1 descendant cleared2015: 1 descendant cleared2011: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK940802 Zipprep ElectrodeAspect Medical Systems, Inc. · 1994
  2. Descendant · cites it directly · 13 of its ownK961821 Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996
  3. Descendant · 2 generations on · 11 of its ownK994330 Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000
  4. Descendant · 3 generations on · 10 of its ownK013389 Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002
  5. Descendant · 4 generations on · 8 of its ownK023459 Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003
  6. Descendant · 5 generations on · 7 of its ownK050835 Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1996: 12000: 12002: 12003: 12005: 32007: 22008: 22009: 12011: 12015: 12023: 12024: 1
1996high 3 (2005) · low 0 (1997)2026

Most influential descendants

Showing 5 of 16 · See all
  • K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc. · 1996 · cites it directly13descendants
  • K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc. · 2000 · 2 generations on11descendants
  • K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda · 2002 · 3 generations on10descendants
  • K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda · 2003 · 4 generations on8descendants
  • K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare · 2005 · 5 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940802Zipprep ElectrodeAspect Medical Systems, Inc.1994—
+1K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc.1996—
+2K994330Aspect Medical Systems Eeg Sensor, Model 186-0076Aspect Medical Systems, Inc.2000—
+3K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesDatex-Ohmeda2002—
+4K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesDatex-Ohmeda2003—
+5K050835Datex-Ohmeda S/5TM Entropy Module, E-Entropy and AccessoriesGE Healthcare2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200010
200210
200310
200530
200720
200820
200910
201110
201510
202310
202410
FIG. 1 — Lineage of K940802, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · 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 DRX? 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? (16)

See all 16

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961821Aspect Medical Systems Zipprep Eeg SensorAspect Medical Systems, Inc.199613
K050313Bis SRS (Semi-Resuable Sensor)Aspect Medical Systems, Inc.20051
K070069Zipprep ElectrodeAspect Medical Systems, Inc.20070

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?

  • Of its descendants, K961821 (Aspect Medical Systems, Inc., 1996) has gone furthest, with 13 descendants of its own.

How does its category compare?

All DRX devices

DRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRX

1in 2017

2007: 32008: 32009: 72010: 52013: 12014: 12017: 1
2007high 7 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRX

78in 2010

2007: 147 days median2008: 17 days median2009: 89 days median2010: 78 days median
2007high 147 (2007) · low 17 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRX

6in 2022

2010: 42015: 12020: 52021: 12022: 6
2007high 6 (2022) · low 0 (2007)2026

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

Adverse event reports per year · DRX

250in 2025

2007: 472008: 152009: 362010: 482011: 802012: 412013: 702014: 272015: 582016: 372017: 552018: 432019: 502020: 532021: 552022: 612023: 1132024: 612025: 250
2007high 250 (2025) · low 15 (2008)2025

MAUDE reports naming product code DRX, 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
20073147047
2008317015
2009789036
2010578448
20110—080
20120—041
20131—070
20141—027
20150—158
20160—037
20171—055
20180—043
20190—050
20200—553
20210—155
20220—661
20230—0113
20240—061
20250—0250
20260—0—

More from Aspect Medical Systems, Inc.

25 FDA decisions under this applicant name. See the company

  • K093183Bis Quatro SensorAspect Medical Systems, Inc. · 2009
  • K091854Bis Click Sensor/CableAspect Medical Systems, Inc. · 2009
  • K072286Bis Eeg Vista Monitor System and BisxAspect Medical Systems, Inc. · 20071 recall
  • K062613Bis Eeg Monitor ViewAspect Medical Systems, Inc. · 2007
  • K070069Zipprep ElectrodeAspect Medical Systems, Inc. · 2007

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The DRX category page

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https://510kreport.com/device/K940802 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940802: Zipprep Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940802

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