510(k) Report

510(k) · Cleared

Cleared

Medac System/3

K914925510(k) TraditionalCleared Oct 21, 1993717-day reviewClass II21 CFR 882.5050

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

Davicon, Inc. · HCC Device, Biofeedback

Cleared on Oct 21, 1993 after a 717-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Oct 21, 1993
Review
717 days
Class
Class II
Product code
HCC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 2 descendants cleared2007: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared1990200020102020
  1. This deviceK914925 Medac System/3Davicon, Inc. · 1993
  2. Descendant · cites it directly · 4 of its ownK023209 Insight Millennium IiiFasstech · 2003
  3. Descendant · 2 generations on · 1 of its ownK063447 Insight DiscoveryFasstech · 2007
  4. Descendant · 3 generations on · 0 of its ownK131094 VimoveDorsa VI Pty., Ltd. · 2014
  5. Descendant · 2 generations on · 0 of its ownK123399 Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013
  6. Descendant · 2 generations on · 0 of its ownK033452 CWAS 1000Fasstech · 2003

Most influential descendants

Showing 5 of 5 · See all
  • K023209Insight Millennium IiiFasstech · 2003 · cites it directly4descendants
  • K063447Insight DiscoveryFasstech · 2007 · 2 generations on1descendant
  • K131094VimoveDorsa VI Pty., Ltd. · 2014 · 3 generations on0descendants
  • K123399Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc. · 2013 · 2 generations on0descendants
  • K033452CWAS 1000Fasstech · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914925Medac System/3Davicon, Inc.1993—
+1K023209Insight Millennium IiiFasstech2003—
+2K063447Insight DiscoveryFasstech2007—
+3K131094VimoveDorsa VI Pty., Ltd.2014—
+2K123399Myovision 3.0 Wirefree SystemPrecision Biometrics, Inc.2013—
+2K033452CWAS 1000Fasstech2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200710
201310
201410
FIG. 1 — Lineage of K914925, 1993–2014Source: 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 HCC? 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 HCC device

  1. #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
  2. #2 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? (5)

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

NumberDeviceApplicantDecidedDescendants
K023209Insight Millennium IiiFasstech20034

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, K023209 (Fasstech, 2003) has gone furthest, with 4 descendants of its own.

How does its category compare?

All HCC devices

HCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCC

1in 2024

2007: 12008: 22010: 12011: 12013: 22015: 22017: 12018: 12023: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCC

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

Recalls per year · HCC

1in 2015

2012: 12015: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · HCC

5in 2024

2007: 22008: 22009: 12011: 42012: 22013: 22014: 22016: 42017: 32018: 12019: 62020: 22022: 32023: 22024: 5
2007high 6 (2019) · low 0 (2010)2025

MAUDE reports naming product code HCC, 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—02
20082—02
20090—01
20101—00
20111—04
20120—12
20132—02
20140—02
20152—10
20160—04
20171—03
20181—01
20190—06
20200—02
20210—00
20220—03
20231—02
20241—05
20250—00
20260—0—

More from Davicon, Inc.

2 FDA decisions under this applicant name. See the company

  • K914920Biofeedback System/3Davicon, Inc. · 1992

Recent decisions in HCC

The HCC category page

  • K233580A Breathing System (ABS)Deepwell Dtx, Inc. · 2024
  • K222101PrismGraymatters Health, Ltd. · 2023
  • K180173FreespiraPalo Alto Health Sciences, Inc. · 2018
  • K163448GrindCare SystemSunstar Suisse S.A. · 2017
  • K151050Pacifier Activated Lullaby (PAL®)Power Medical Devices, LLC · 20151 recall

https://510kreport.com/device/K914925 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914925: Medac System/3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914925

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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