510(k) Report

510(k) · Cleared

Cleared

Noddle (TM)

K162817510(k) TraditionalCleared Jan 18, 2017104-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

Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. · ILQ System, Communication, Powered

Cleared on Jan 18, 2017 as substantially equivalent to K930044 (Health Care Keyboard Co., Inc., 1994) after a 104-day review. Its family tree reaches back 1 generation to 1994.

Decided
Jan 18, 2017
Review
104 days
Class
Class II
Product code
ILQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K930044 (1994). No later device cites it as a predicate yet.

K930044 · Comfort Keyboard System · Health Care Keyboard Co., Inc. · 1994199019952000200520102015
K930044 · Comfort Keyboard System · Health Care Keyboard Co., Inc. · 19940
  1. Root · 1 generation backK930044 Comfort Keyboard SystemHealth Care Keyboard Co., Inc. · 1994
  2. This deviceK162817 Noddle (TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930044Comfort Keyboard SystemHealth Care Keyboard Co., Inc.1994—
0 (this device)K162817Noddle (TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.2017—
FIG. 1 — Lineage of K162817, 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? (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
*K930044Comfort Keyboard System
Summary page 4
…890.3710 Device Class: Class II Device Code: ILQ Predicate device: • Substantially equivalent to Comfort Keyboard (K930044) Device description: The Voxello noddleTM is a patient assistive communication device that accepts signals from a senso…
Health Care Keyboard Co., Inc.1994—

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.

How does its category compare?

All ILQ devices

ILQ System, Communication, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

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—

What is it indicated for?

The Noddle™ is indicated for use by patients who have physical limitations, weaknesses, and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the Noddle™ patients should be sufficiently cognitively intact so that they can produce intentional gestures and intend to communicate with caregivers.

Indications for use as stated in the FDA summary.

Recent decisions in ILQ

The ILQ category page

  • K943035P.a.T. SystemMathews Assoc., Inc. · 1994
  • K930044Comfort Keyboard SystemHealth Care Keyboard Co., 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/K162817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162817: Noddle (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162817

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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