510(k) Report

510(k) · Cleared

Cleared

Miniscope MS-3

K954066510(k) TraditionalCleared Oct 27, 199558-day reviewClass II21 CFR 870.2340

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

Schiller America, Inc. · DPS Electrocardiograph

Cleared on Oct 27, 1995 after a 58-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 67 later devices descend from it.

Decided
Oct 27, 1995
Review
58 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

67 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2002: 2 descendants cleared2005: 3 descendants cleared2010: 5 descendants cleared2009: 1 descendant cleared2008: 3 descendants cleared2011: 4 descendants cleared2023: 6 descendants cleared2007: 1 descendant cleared2012: 3 descendants cleared2015: 3 descendants cleared2013: 2 descendants cleared2018: 3 descendants cleared2014: 2 descendants cleared2019: 3 descendants cleared2016: 2 descendants cleared2020: 4 descendants cleared2017: 2 descendants cleared2026: 6 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared2025: 4 descendants cleared1995200020052010201520202025
  1. This deviceK954066 Miniscope MS-3Schiller America, Inc. · 1995
  2. Descendant · cites it directly · 66 of its ownK990809 Cadiscope Electronic StethoscopeCaditec AG · 1999
  3. Descendant · 2 generations on · 46 of its ownK013434 VP-2000/1000Colin Corp. · 2002
  4. Descendant · 3 generations on · 27 of its ownK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
  5. Descendant · 2 generations on · 16 of its ownK013725 Meditron II Thesterthoscope SystemMeditron AS · 2002
  6. Descendant · 4 generations on · 15 of its ownK151869 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

1999: 12002: 22005: 32007: 12008: 32009: 12010: 52011: 42012: 32013: 22014: 22015: 32016: 22017: 22018: 32019: 32020: 42021: 22022: 22023: 62024: 32025: 42026: 6
1999high 6 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 67 · See all
  • K990809Cadiscope Electronic StethoscopeCaditec AG · 1999 · cites it directly66descendants
  • K013434VP-2000/1000Colin Corp. · 2002 · 2 generations on46descendants
  • K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH · 2008 · 3 generations on27descendants
  • K013725Meditron II Thesterthoscope SystemMeditron AS · 2002 · 2 generations on16descendants
  • K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954066Miniscope MS-3Schiller America, Inc.1995—
+1K990809Cadiscope Electronic StethoscopeCaditec AG1999—
+2K013434VP-2000/1000Colin Corp.2002—
+3K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp…Microlife Intellectual Property GmbH2008—
+2K013725Meditron II Thesterthoscope SystemMeditron AS2002—
+4K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200220
200530
200710
200830
200910
201050
201140
201230
201320
201420
201530
201620
201720
201830
201930
202040
202120
202220
202360
202430
202540
202660
FIG. 1 — Lineage of K954066, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (67)

See all 67

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990809Cadiscope Electronic StethoscopeCaditec AG199966

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, K990809 (Caditec AG, 1999) has gone furthest, with 66 descendants of its own.

How does its category compare?

All DPS devices

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

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

More from Schiller America, Inc.

10 FDA decisions under this applicant name. See the company

  • K973735Microvit MT-100Schiller America, Inc. · 1998
  • K973751MT-200Schiller America, Inc. · 1998
  • K970879Cardiovit CS-200Schiller America, Inc. · 1997
  • K953396Cardiovit at-1C, at-2CSchiller America, Inc. · 1995
  • K941462Cardiovit at-5CSchiller America, Inc. · 1995

Recent decisions in DPS

The DPS category page

  • K260640Kinetic Software LibraryMonebo Technologies, Inc. · 2026
  • K260005MyoVista wavECG (DG-200-B15-003)HeartSciences, Inc. · 2026
  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K254255S-Patch CardioAIWellysis Corp. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K954066 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954066: Miniscope MS-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954066

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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