510(k) Report

510(k) · Cleared

Cleared

Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry Airway, Model Number SA-100

K960593510(k) TraditionalCleared May 10, 199688-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

Aradigm Corp. · CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Cleared on May 10, 1996 as substantially equivalent to K940835 (Medtrac Technologies Corp., 1994) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided
May 10, 1996
Review
88 days
Class
Class I
Product code
CCQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K872037 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1989: 1 other ancestor2005: 1 descendant clearedK872037 · Aerochamber · Monaghan Medical Corp. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K872037 · Aerochamber · Monaghan Medical Corp. · 19870
  1. Root · 1 generation backK872037 AerochamberMonaghan Medical Corp. · 1987
  2. This deviceK960593 Smartmist Asthma Managment System, Smartmist, Model Number…Aradigm Corp. · 1996
  3. Descendant · cites it directly · 0 of its ownK051284 MD TurboRespirics, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K051284MD TurboRespirics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872037AerochamberMonaghan Medical Corp.1987—
0 (this device)K960593Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist…Aradigm Corp.1996—
+1K051284MD TurboRespirics, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K960593, 1987–2005Source: 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.

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  • 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? (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
*K940835Peaklog and Display Software
Summary page 1
…ed Dose Ir:haler, classification unknown / Meter, peak flow, spiromerry, 21 CFR § 868.1860 3. Predicate Devices: i. MEDTRAC Technologies, Inc. PeakLog™ Peck Flow Meter, K940835 . Vitalograph Inc. A.L.M. - Aerosol Inhalation Monitor, K893665 iil. Monaghan Medical AeroChamber® MDI Acc :ssory, K872037 4. De…
Medtrac Technologies Corp.1994—
*K893665Aerosol Inhalation Monitor
Summary page 1
…romerry, 21 CFR § 868.1860 3. Predicate Devices: i. MEDTRAC Technologies, Inc. PeakLog™ Peck Flow Meter, K940835 . Vitalograph Inc. A.L.M. - Aerosol Inhalation Monitor, K893665 iil. Monaghan Medical AeroChamber® MDI Acc :ssory, K872037 4. Description of Device: The Aradigm Corporation SmartMist™ Asthma…
Vitalograph, Ltd.1989—
*K872037Aerochamber
Summary page 1
…C Technologies, Inc. PeakLog™ Peck Flow Meter, K940835 . Vitalograph Inc. A.L.M. - Aerosol Inhalation Monitor, K893665 iil. Monaghan Medical AeroChamber® MDI Acc :ssory, K872037 4. Description of Device: The Aradigm Corporation SmartMist™ Asthma Management System is a single patient use prescribed metere…
Monaghan Medical Corp.1987—

Also cleared against K940835: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K051284MD TurboRespirics, Inc.20050

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K051284 (Respirics, Inc., 2005) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K940835.

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—

What is it indicated for?

The Aradigm Corporation SmartMist™ Asthma Management System is intended for use by asthma patients who self medicate with metered dose inhalers (MDI) and who measure peak expiratory flow rate (PEFR) as part of their asthma management programs.

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 K940835

1 other device cites the same predicate.

  • K970344Mdilog, Model MDC-511Medtrak Technologies, Inc. · 1997

Recent decisions in CCQ

The CCQ category page

  • K972397EZ SprayIntertex Research, Inc. · 1997
  • K964956E-Z Spacer Mask (Small)Airpharma, LLC · 1997
  • K961894Mdi TutorMdi Tutor, Inc. · 1996
  • K961455Medshield/AerochamberDiemolding Corp. · 1996
  • K922033Saline Solution- SterileTrinity Laboratories, Inc. · 1992

https://510kreport.com/device/K960593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960593: Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry Airway, Model Number SA-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960593

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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