510(k) Report

510(k) · Cleared

Cleared

Nebulizer Chronolog & Interpreter

K823423510(k) TraditionalCleared Dec 15, 198229-day reviewClass I21 CFR 868.5640

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

Advanced Technology Products, Inc. · CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Cleared on Dec 15, 1982 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.

Decided
Dec 15, 1982
Review
29 days
Class
Class I
Product code
CCQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2014: 2 descendants cleared2018: 4 descendants cleared2017: 1 descendant cleared2015: 3 descendants cleared2019: 3 descendants cleared2023: 2 descendants cleared2016: 3 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2020: 1 descendant cleared19801990200020102020
  1. This deviceK823423 Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc. · 1982
  2. Descendant · cites it directly · 27 of its ownK970344 Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997
  3. Descendant · 2 generations on · 25 of its ownK091803 Smarttrack SystemNexus6, Ltd. · 2009
  4. Descendant · 3 generations on · 13 of its ownK121609 Asthmapolis SystemReciprocal Labs Corporation · 2012
  5. Descendant · 4 generations on · 12 of its ownK140638 Propeller System - Model 2Reciprocal Labs Corporation · 2014
  6. Descendant · 3 generations on · 10 of its ownK133951 SmarttouchNexus6, Ltd. · 2014

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1997: 12006: 12009: 12012: 12014: 22015: 32016: 32017: 12018: 42019: 32020: 12021: 22022: 12023: 22025: 12026: 1
1997high 4 (2018) · low 0 (1998)2026

Most influential descendants

Showing 5 of 28 · See all
  • K970344Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997 · cites it directly27descendants
  • K091803Smarttrack SystemNexus6, Ltd. · 2009 · 2 generations on25descendants
  • K121609Asthmapolis SystemReciprocal Labs Corporation · 2012 · 3 generations on13descendants
  • K140638Propeller System - Model 2Reciprocal Labs Corporation · 2014 · 4 generations on12descendants
  • K133951SmarttouchNexus6, Ltd. · 2014 · 3 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K823423Nebulizer Chronolog & InterpreterAdvanced Technology Products, Inc.1982—
+1K970344Mdilog, Model MDC-511Medtrak Technologies, Inc.1997—
+2K091803Smarttrack SystemNexus6, Ltd.2009—
+3K121609Asthmapolis SystemReciprocal Labs Corporation2012—
+4K140638Propeller System - Model 2Reciprocal Labs Corporation2014—
+3K133951SmarttouchNexus6, Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200610
200910
201210
201420
201530
201630
201710
201840
201930
202010
202120
202210
202320
202510
202610
FIG. 1 — Lineage of K823423, 1982–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CCQ? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K970344Mdilog, Model MDC-511Medtrak Technologies, Inc.199727

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, K970344 (Medtrak Technologies, Inc., 1997) has gone furthest, with 27 descendants of its own.

How does its category compare?

All CCQ devices

CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCQ

FDA has decided no CCQ device since 2007.

Median 510(k) review, days · CCQ

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

Recalls per year · CCQ

5in 2016

2011: 12016: 5
2007high 5 (2016) · low 0 (2007)2026

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

Adverse event reports per year · CCQ

30in 2025

2007: 32008: 52009: 42010: 152011: 102012: 72013: 2072014: 982015: 1322016: 182017: 132019: 42020: 12021: 22023: 72024: 72025: 30
2007high 207 (2013) · low 0 (2018)2025

MAUDE reports naming product code CCQ, 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—03
20080—05
20090—04
20100—015
20110—110
20120—07
20130—0207
20140—098
20150—0132
20160—518
20170—013
20180—00
20190—04
20200—01
20210—02
20220—00
20230—07
20240—07
20250—030
20260—0—
Cite this page

510(k) Report. “K823423: Nebulizer Chronolog & Interpreter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K823423

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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