510(k) Report

510(k) · Cleared

Cleared

Comfort Keyboard System

K930044510(k) TraditionalCleared Jul 14, 1994555-day reviewClass II21 CFR 890.3710

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

Health Care Keyboard Co., Inc. · ILQ System, Communication, Powered

Cleared on Jul 14, 1994 after a 555-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided
Jul 14, 1994
Review
555 days
Class
Class II
Product code
ILQ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared1990200020102020
  1. This deviceK930044 Comfort Keyboard SystemHealth Care Keyboard Co., Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK162817 Noddle (TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K162817Noddle (TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930044Comfort Keyboard SystemHealth Care Keyboard Co., Inc.1994—
+1K162817Noddle (TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K930044, 1994–2017Source: 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 ILQ? 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?

The FDA summary names no predicate by number.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K162817Noddle (TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.20170

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, K162817 (Iowa Adaptive Technologies, Inc. Dba Voxello, Inc., 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All ILQ devices

ILQ System, Communication, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILQ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILQ

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

Recalls per year · ILQ

2in 2021

2009: 12011: 12013: 12015: 12021: 22026 (partial year): 2
2007high 2 (2021) · low 0 (2007)2026

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

Adverse event reports per year · ILQ

240in 2025

2007: 42008: 72009: 52010: 142011: 162012: 132013: 142014: 122016: 42017: 72018: 72019: 22020: 22021: 52022: 272023: 742024: 1052025: 240
2007high 240 (2025) · low 0 (2015)2025

MAUDE reports naming product code ILQ, 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
20070—04
20080—07
20090—15
20100—014
20110—116
20120—013
20130—114
20140—012
20150—10
20160—04
20171—07
20180—07
20190—02
20200—02
20210—25
20220—027
20230—074
20240—0105
20250—0240
20260—2—

Recent decisions in ILQ

The ILQ category page

  • K162817Noddle (TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. · 2017
  • K943035P.a.T. SystemMathews Assoc., Inc. · 1994
  • K931855LightwriterZygo Corp. · 1994
  • K935244R & D Batteries, Inc. Part Number 5113R & D Batteries, Inc. · 1994
  • K935981MLT-2Med Labs, Inc. · 1994

https://510kreport.com/device/K930044 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930044: Comfort Keyboard System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930044

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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