510(k) Report

510(k) · Cleared

Cleared

Pill Phone

K060298510(k) TraditionalCleared Mar 29, 200651-day reviewClass I21 CFR 890.5050

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

Vocel · NXQ Reminder, Medication

Cleared on Mar 29, 2006 after a 51-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.

Decided
Mar 29, 2006
Review
51 days
Class
Class I
Product code
NXQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2014: 1 descendant cleared2022: 3 descendants cleared2016: 1 descendant cleared2023: 1 descendant cleared2026: 3 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK060298 Pill PhoneVocel · 2006
  2. Descendant · cites it directly · 9 of its ownK140086 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014
  3. Descendant · 2 generations on · 4 of its ownK213519 Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022
  4. Descendant · 3 generations on · 3 of its ownK220820 Parky AppH2o Bilisim Yazilim · 2022
  5. Descendant · 2 generations on · 3 of its ownK161717 Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016
  6. Descendant · 4 generations on · 1 of its ownK250153 Neu PlatformNeuhealth Digital, Ltd. · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014: 12016: 12022: 32023: 12025: 12026: 3
2014high 3 (2022) · low 0 (2015)2026

Most influential descendants

Showing 5 of 10 · See all
  • K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2014 · cites it directly9descendants
  • K213519Rune Labs Tremor Transducer SystemRune Labs, Inc. · 2022 · 2 generations on4descendants
  • K220820Parky AppH2o Bilisim Yazilim · 2022 · 3 generations on3descendants
  • K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd. · 2016 · 2 generations on3descendants
  • K250153Neu PlatformNeuhealth Digital, Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060298Pill PhoneVocel2006—
+1K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.2014—
+2K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.2022—
+3K220820Parky AppH2o Bilisim Yazilim2022—
+2K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.2016—
+4K250153Neu PlatformNeuhealth Digital, Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201610
202230
202310
202510
202630
FIG. 1 — Lineage of K060298, 2006–2026Source: 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 NXQ? 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
Get a 510(k) Report

What was it cleared against? (3)

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
*—Oncellrx
Named without a submission number
—
*—Medpartner
Named without a submission number
—
*—various medication reminder systems marketed by E-Pill, LLC
Named without a submission number
—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149

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, K140086 (Gkc Manufacturing Pty, Ltd., 2014) has gone furthest, with 9 descendants of its own.

How does its category compare?

All NXQ devices

NXQ Reminder, Medication: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NXQ

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NXQ

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

Recalls per year · NXQ

No recall names NXQ since 2007.

Adverse event reports per year · NXQ

1in 2024

2014: 12016: 12018: 12019: 22020: 12024: 1
2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code NXQ, 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—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—01
20150—00
20160—01
20170—00
20180—01
20190—02
20200—01
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K060298: Pill Phone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060298

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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