510(k) Report

510(k) · Cleared

Cleared

Insight Genesis

K011983510(k) TraditionalCleared Aug 30, 200165-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

Fasstech · HCC Device, Biofeedback

Cleared on Aug 30, 2001 as substantially equivalent to K990778 (Fasstech, 1999) after a 65-day review. Its family tree reaches back 1 generation to 1999.

Decided
Aug 30, 2001
Review
65 days
Class
Class II
Product code
HCC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K990778 (1999). No later device cites it as a predicate yet.

K990778 · Insight Millennium · Fasstech · 19991996199820002002
K990778 · Insight Millennium · Fasstech · 19990
  1. Root · 1 generation backK990778 Insight MillenniumFasstech · 1999
  2. This deviceK011983 Insight GenesisFasstech · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K990778Insight MillenniumFasstech1999—
0 (this device)K011983Insight GenesisFasstech2001—
FIG. 1 — Lineage of K011983, 1999–2001Source: 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), 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 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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K990778Insight Millennium
Summary page 3
…Device This section documents the substantial equivalence of the Insight Genesis to legally marketed devices. The Insight Genesis is a subset of the Insight Millennium (K990778). The Insight Millennium is a multi-modality device containing four surface EMG sensors, an infrared thermal scanner and an incli…
Fasstech1999—

Also cleared against K990778: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K990778.

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—

What is it indicated for?

To measure bilateral differences in surface EMG along the spine

To measure surface EMG along the spine during functional tasks

To chart patient progress during the course of treatment

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K990778

1 other device cites the same predicate.

  • K011964Insight Millennium PlusFasstech · 2001

More from Fasstech

9 FDA decisions under this applicant name. See the company

  • K063447Insight DiscoveryFasstech · 2007
  • K033452CWAS 1000Fasstech · 2003
  • K023209Insight Millennium IiiFasstech · 2003
  • K011964Insight Millennium PlusFasstech · 2001
  • K990778Insight MillenniumFasstech · 1999

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/K011983 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011983: Insight Genesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011983

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026